93/42/eec medical devices - consultants industrie ......*mds 7002 - medical devices utilising...

TÜV NORD CERT GmbHLangemarckstraße 2045141 ESSENGermany

0044 *MD 1300 - Monitoring devices

- *MD 1301 - Monitoring devices of non-vital

physiological parameters

- *MD 1302 - Monitoring devices of vital physiological

parameters

*MD 1400 - Devices for radiation therapy and thermo

therapy

- *MD 1401 - Devices utilising ionizing radiation

- *MD 1402 - Devices utilising non-ionizing radiation

Full quality assurance

system

EC type-examination

EC verification

Production quality

assurance

Product quality assurance

Annex II

Annex III

Annex IV

Annex V

Annex VI

*MD 0100 - General non-active, non-implantable

medical devices

- *MD 0102 - Non-active devices for injection, infusion,

transfusion and dialysis

- *MD 0101 - Non-active devices for anaesthesia,

emergency and intensive care

- *MD 0103 - Non-active orthopaedic and rehabilitation

devices

- *MD 0104 - Non-active medical devices with

measuring function

- *MD 0105 - Non-active ophthalmologic devices

- *MD 0106 - Non-active instruments

- *MD 0107 - Contraceptive medical devices

- *MD 0108 - Non-active medical devices for

disinfecting, cleaning, rinsing

- *MD 0109 - Non-active devices for in vitro fertilisation

(IVF) and assisted reproductive technologies (ART)

*MD 0200 - Non-active implants


system

Production quality

assurance


Annex II

Annex V

Annex VI

Creation Date : 25/02/2016

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices

Name and address of the notifiedbodies

ID Responsible for the following products/Horizontal technical competence

Responsible for thefollowing procedures

or modules

Annexes orarticles of the

directives

Limitations (English only)

1 / 301

- *MD 0201 - Non-active cardiovascular implants

- *MD 0202 - Non-active orthopaedic implants

- *MD 0203 - Non-active functional implants

- *MD 0204 - Non-active soft tissue implants

*MD 0300 - Devices for wound care

- *MD 0301 - Bandages and wound dressings

- *MD 0302 - Suture material and clamps

- *MD 0303 - Other medical devices for wound care

*MD 0400 - Non-active dental devices and accessories

- *MD 0401 - Non-active dental equipment and

instruments

- *MD 0402 - Dental materials

- *MD 0403 - Dental implants

*MD 1100 - General active medical devices

- *MD 1101 - Devices for extra-corporal circulation,

infusion and haemopheresis

- *MD 1102 - Respiratory devices, devices including

hyperbaric chambers for oxygen therapy, inhalation

anaesthesia

- *MD 1103 - Devices for stimulation or inhibition

- *MD 1104 - Active surgical devices

- *MD 1105 - Active ophthalmologic devices

- *MD 1106 - Active dental devices

- *MD 1107 - Active devices for disinfection and

sterilisation

- *MD 1108 - Active rehabilitation devices and active


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


2 / 301

prostheses

- *MD 1109 - Active devices for patient positioning and

transport


- *MD 1111 - Software


system

Production quality

assurance


Annex II

Annex V

Annex VI

*MD 1200 - Devices for imaging

- *MD 1201 - Imaging devices utilising ionizing

radiation

- *MD 1202 - Imaging devices utilising non-ionizing

radiation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

*MDS 7001 - Medical devices incorporating medicinal

substances, according to Directive 2001/83/EC

*MDS 7002 - Medical devices utilising tissues of animal

origin, including Regulation 722/2012 (Directive

2003/32/EC up to 28.08.2013)

without medical devices according

to Commission Regulation (EU) No

722/2012

*MDS 7004 - Medical devices referencing the Directive

2006/42/EC on machinery

for active medical devices only

*MDS 7006 - Medical devices in sterile condition

*MDS 7009 - Medical devices utilising biological active

coatings and/or materials or being wholly or mainly

absorbedNational Standards Authority of Ireland (NSAI) 0050 *MD 0100 - General non-active, non-implantable EC declaration of Annex II






or modules


directives


3 / 301

1 Swift Square, Northwood, SantryDublin 9Ireland

medical devices






devices


measuring function


















conformity (full quality

assurance system)

EC declaration of

conformity (production

quality assurance)

EC declaration of

conformity (product quality

assurance)

Annex V

Annex VI






or modules


directives


4 / 301


instruments








anaesthesia





sterilisation


transport




radiation


radiation

*MD 1300 - Monitoring devices









or modules


directives


5 / 301

parameters


therapy


- *MD 1403 - Devices for hyperthermia / hypothermia

- *MD 1404 - Devices for (extracorporal) shock-wave

therapy (lithotripsy)





2003/32/EC up to 28.08.2013)

*MDS 7003 - Medical devices incorporating derivates of

human blood, according to Directive 2000/70/EC,

amended by Directive 2001/104/EC




*MDS 7007 - Medical devices utilising micromechanics



absorbedIMQ ISTITUTO ITALIANO DEL MARCHIO DIQUALITÀ S.P.A.Via Quintiliano, 4320138 - MILANOItaly

0051 *MD 0100 - General non-active, non-implantable

medical devices



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI

exclusion medical devices class III






or modules


directives


6 / 301

quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


7 / 301

EC declaration of


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


8 / 301


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


9 / 301

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


10 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


11 / 301

assurance)




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


- hyperbaric chambers only annex

II - V - VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II

Annex V







or modules


directives


12 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


13 / 301

assurance)



sterilisation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




transport

EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II

Annex V







or modules


directives


14 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


*MD 1200 - Devices for imaging EC type-examination Annex III exclusion medical devices class III






or modules


directives


15 / 301


radiation

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




parameters

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


16 / 301

quality assurance)

EC declaration of


assurance)


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy

EC type-examination Annex III exclusion medical devices class III-

exclusion devices for hypothermia






or modules


directives


17 / 301

- *MD 1403 - Devices for hyperthermia / hypothermia EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI


therapy



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






89/686/EEC on personal protective equipment (PPE)


*MDS 7006 - Medical devices in sterile condition exclusion medical devices class IIIIRCM ISTITUTO DI RICERCHE E COLLAUDIMASINI S.R.L.


medical devices

EC type-examination Annex III Except class III Medical Devices






or modules


directives


18 / 301

Via Moscova, 1120017 - Rho (MI)Italy



EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

Except class III Medical Devices


medical devices


measuring function

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


19 / 301

quality assurance)

EC declaration of


assurance)


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



medical devices

EC type-examination Annex III Except class III Medical Devices






or modules


directives


20 / 301

- *MD 0107 - Contraceptive medical devices EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


21 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


Except suture material



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 0400 - Non-active dental devices and accessories EC declaration of Annex II Except class III Medical Devices






or modules


directives


22 / 301

- *MD 0402 - Dental materials conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


23 / 301




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Except hyperbaric chambers



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


24 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


25 / 301



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Except active prostheses



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


26 / 301

assurance)



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II

Annex V







or modules


directives


27 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



parameters

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


28 / 301

assurance)


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Except Devices for hypothermia












or modules


directives


29 / 301

*MDS 7006 - Medical devices in sterile condition Except class III Medical DevicesBSIKitemark Court Davy Avenue KnowhillMilton Keynes MK5 8PPUnited Kingdom


medical devices






devices


measuring function









system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices

- *MD 0110 - Non-active medical devices for ingestion

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


30 / 301


assurance)












instruments








anaesthesia






system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


31 / 301


sterilisation


prostheses


transport

- *MD 1110 - Active devices for in vitro fertilisation

(IVF) and assisted reproductive therapy (ART)



- *MD 1112 - Medical gas supply systems and parts

thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



radiation


radiation




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


32 / 301



parameters


therapy










2003/32/EC up to 28.08.2013)







*MDS 7008 - Medical devices utilising nanomaterials



absorbed

*MDS 7010 - Medical devices incorporating software

/utilising software /controlled by software






or modules


directives


33 / 301

LLOYD'S REGISTER QUALITY ASSURANCELTD (0088)Hiramford Middlemarch Office Village SiskinDriveCoventry CV3 4FJUnited Kingdom


medical devices






devices


measuring function


















system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


34 / 301



instruments








anaesthesia






sterilisation


prostheses


transport






radiation






or modules


directives


35 / 301


radiation





parameters


therapy










2003/32/EC up to 28.08.2013)








absorbed






or modules


directives


36 / 301

SGS United Kingdom LimitedUnit 202B, Worle Parkway,Weston-super-Mare, Somerset, BS22 6WAUnited Kingdom


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


37 / 301

- *MD 0106 - Non-active instruments Production quality

assurance


Annex VI


medical devices



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

Annex III - condoms (with and

without spermicide) Annex IV -

condoms (with and without

spermicide)


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


38 / 301

Production quality

assurance


Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


39 / 301




instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI





system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Annex III - Infusion pumps Annex

III - Dialysis equipment




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


40 / 301




system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Annex III - Defibrillators (External)




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI

*MD 1100 - General active medical devices Full quality assurance Annex II






or modules


directives


41 / 301


prostheses

system

Production quality

assurance


Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


42 / 301

assurance






system

EC verification

Production quality

assurance


Annex II

Annex IV

Annex V

Annex VI

Annex IV - Clinical Thermometers

Annex IV - Active Medical Devices

(Class I Measuring and IIa only)



parameters


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

Annex III - ECG Monitors Annex IV

- Active Medical Devices (Class I

Measuring and IIa only)


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy


system

Annex II






or modules


directives


43 / 301

- *MD 1403 - Devices for hyperthermia / hypothermia Production quality

assurance


Annex V

Annex VI


therapy




system

Production quality

assurance


Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)






absorbedTÜV SÜD Product Service GmbHZertifizierstellenRidlerstraße 6580339 MÜNCHENGermany

0123 *MD 0300 - Devices for wound care






instruments



system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


44 / 301







anaesthesia






sterilisation


prostheses


transport




radiation


radiation






system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


45 / 301

parameters


therapy







medical devices






medical devices


devices


measuring function







system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex III






or modules


directives


46 / 301





EC type-examination

EC verification

Production quality

assurance


Annex IV

Annex V

Annex VI






system

Production quality

assurance


Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)







or modules


directives


47 / 301











absorbedDEKRA Certification GmbHHandwerkstraße 1570565 STUTTGARTGermany


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


48 / 301


measuring function

Production quality

assurance


Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Annex III for condoms only


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


49 / 301

(IVF) and assisted reproductive technologies (ART) assurance





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


50 / 301




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex III






or modules


directives


51 / 301

infusion and haemopheresis EC type-examination

EC verification

Production quality

assurance


Annex IV

Annex V

Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


52 / 301

Production quality

assurance


Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI



prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



transport


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


53 / 301




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



radiation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



radiation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





system

EC type-examination

EC verification

Production quality

Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


54 / 301

assurance




parameters


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


therapy



system

EC type-examination

EC verification

Production quality

Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


55 / 301

assurance



therapy




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





2003/32/EC up to 28.08.2013)









absorbedTÜV Rheinland LGA Products GmbHTillystraße 290431 NürnbergGermany

0197 *MD 0200 - Non-active implants



system

EC type-examination

EC verification

Annex II

Annex III

Annex IV

Annex V






or modules


directives


56 / 301

Production quality

assurance


Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


57 / 301




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI



transport





anaesthesia




system

EC type-examination

EC verification

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assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


58 / 301




sterilisation


prostheses





medical devices




devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices



system

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assurance


Annex II

Annex V

Annex VI






or modules


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59 / 301


medical devices



system

EC type-examination

EC verification

Production quality

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Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices








system

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assurance


Annex II

Annex V

Annex VI



radiation


radiation





parameters


therapy


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


60 / 301










2003/32/EC up to 28.08.2013)









absorbedDQS Medizinprodukte GmbHAugust-Schanz-Straße 2160433 FRANKFURT AM MAINGermany

0297 *MD 1200 - Devices for imaging


radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


61 / 301






system

Production quality

assurance


Annex II

Annex V

Annex VI



parameters


system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy




system

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Annex II

Annex V

Annex VI

*MD 0100 - General non-active, non-implantable Full quality assurance Annex II






or modules


directives


62 / 301

medical devices



system

Production quality

assurance

Annex V


medical devices




system

Production quality

assurance

Annex II

Annex V


medical devices


devices


system

Production quality

assurance

Annex II

Annex V


medical devices


measuring function


system

Production quality

assurance

Annex II

Annex V


medical devices



system

Production quality

assurance

Annex II

Annex V


medical devices



system

Production quality

assurance

Annex II

Annex V


medical devices



system

Production quality

assurance

Annex II

Annex V

condoms only






or modules


directives


63 / 301


medical devices




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V

vascular implants only




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

Production quality

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Annex II

Annex V




system

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Annex II

Annex V






or modules


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64 / 301

assurance




system

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Annex II

Annex V



instruments


system

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Annex II

Annex V




system

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Annex II

Annex V




system

Production quality

assurance

Annex II

Annex V




system

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Annex II

Annex V

Annex VI




system

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Annex II

Annex V

Annex VI






or modules


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65 / 301




system

Production quality

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Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI



prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


66 / 301

infusion and haemopheresis Production quality

assurance


Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)









absorbedAGENCIA ESPAÑOLA DE MEDICAMENTOS 0318 *MD 1200 - Devices for imaging EC type-examination Annex III






or modules


directives


67 / 301

Y PRODUCTOS SANITARIOSCampezo 1. Edificio 828022 MADRIDSpain


radiation


radiation





parameters


therapy







medical devices






devices


measuring function


EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI






or modules


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68 / 301


















instruments








sterilisation






or modules


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69 / 301


prostheses


transport








anaesthesia






2003/32/EC up to 28.08.2013)















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70 / 301

absorbedDEKRA Certification B.V.Meander 1051 / P.O. Box 51856825 MJ ARNHEM / 6802 ED ARNHEMNetherlands


medical devices






devices


measuring function
















EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


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71 / 301




instruments








anaesthesia






sterilisation


prostheses


transport











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72 / 301

radiation


radiation





parameters


therapy










2003/32/EC up to 28.08.2013)













or modules


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absorbed


/utilising software /controlled by softwareISTITUTO SUPERIORE DI SANITA'Viale Regina Elena, 29900161 - ROMAItaly

0373 All medical devices Full quality assurance

system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

SP Sveriges Tekniska Forskningsinstitut AB/SP Technical Research Institute of SwedenBox 857501 15 BORASSweden



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

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Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


74 / 301


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Bone-anchored implants for dental

and cranio-facial reconstruction



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI

Bone-anchored implants for dental

and cranio-facial reconstruction




system

Annex II

Annex V






or modules


directives


75 / 301


anaesthesia

Production quality

assurance


Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



*MDS 7006 - Medical devices in sterile conditionTÜV AUSTRIA SERVICES GMBHKrugerstrasse 161015 WIENAustria


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


76 / 301


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


devices

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


measuring function

EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


77 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


78 / 301


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


79 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

neurological and neurosurgical

implants excluded






or modules


directives


80 / 301



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


81 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



instruments

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


82 / 301



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


83 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


84 / 301



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



sterilisation

EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


85 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


86 / 301




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


87 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


88 / 301



parameters

EC type-examination

EC verification

EC declaration of


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EC declaration of


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EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


89 / 301

EC declaration of


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EC declaration of


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therapy


EC type-examination

EC verification

EC declaration of


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EC declaration of


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EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI


therapy



EC type-examination

EC verification

EC declaration of


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EC declaration of


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EC declaration of


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Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


90 / 301





2003/32/EC up to 28.08.2013)

tissues according directive

2003/32/EC excluded











absorbed


/utilising software /controlled by softwareINTERTEK SEMKO ABTorshamnsgatan 43 Box 1103SE-164 22 KISTASweden


medical devices



EC declaration of


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EC declaration of


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EC declaration of


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Annex II

Annex V

Annex VI






or modules


directives


91 / 301


medical devices




devices


measuring function
















instruments




system

Production quality

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Annex II

Annex V

Annex VI






or modules


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92 / 301






anaesthesia






sterilisation


prostheses


transport




radiation


radiation





parameters

EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex II

Annex V

Annex VI






or modules


directives


93 / 301


therapy






*MDS 7006 - Medical devices in sterile conditionITALCERT SRLViale Sarca, 33620126 - MILANOItaly


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


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Annex II

Annex V

Annex VI

exclusion medical devices class III,

except surgically devices, intended

for transient use, in direct contact

with central nervous system


medical devices

EC declaration of


Annex II exclusion medical devices class III






or modules


directives


94 / 301


devices

assurance system)

EC declaration of


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EC declaration of


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Annex V

Annex VI


medical devices


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EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


95 / 301

EC declaration of


quality assurance)

EC declaration of


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medical devices


EC declaration of


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EC declaration of


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EC declaration of


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Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


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EC declaration of


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Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI


except hip, knee and shoulder joint

replacements and except

orthopaedic implants utilizing






or modules


directives


96 / 301


quality assurance)

EC declaration of


assurance)

biological active coatings and/or

materials or being wholly or mainly

absorbed



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


97 / 301

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


98 / 301

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


except dental implants utilizing

biological active coatings and/or

materials or being wholly or mainly

absorbed




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


99 / 301


assurance)




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


100 / 301

assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


101 / 301



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 1300 - Monitoring devices EC declaration of Annex II exclusion medical devices class III






or modules


directives


102 / 301




assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy

EC declaration of


Annex II

Annex V







or modules


directives


103 / 301

- *MD 1403 - Devices for hyperthermia / hypothermia assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI




*MDS 7006 - Medical devices in sterile condition exclusion medical devices class III,



with central nervous system; hip,

knee and shoulder joint

replacements and orthopaedic and

dental implants utilizing biological

active coatings and/or materials or

being wholly or mainly absorbed



absorbed

Orthopaedic and dental implants

only

Materialprüfungsamt Nordrhein-Westfalen(MPA NRW)Marsbruchstraße 18644287 DortmundGermany

0432 *MD 1300 - Monitoring devices




system

Production quality

assurance


Annex II

Annex V

Annex VI

DNV GL Business Assurance Norway ASVeritasveien 11322 HOVIK

0434 *MD 0400 - Non-active dental devices and accessories



system

Annex II

Annex V






or modules


directives


104 / 301

Norway instruments








anaesthesia






sterilisation


prostheses


transport






radiation


radiation

Production quality

assurance






or modules


directives


105 / 301





parameters


therapy







medical devices




devices


measuring function













or modules


directives


106 / 301
















2003/32/EC up to 28.08.2013)






DNV is also a NB for that directive





absorbed






or modules


directives


107 / 301

Laboratoire national d'essais / G-MED1, rue Gaston Boissier75724 PARIS Cedex 15France


medical devices






devices


measuring function


















system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


108 / 301



instruments








anaesthesia






sterilisation


prostheses


transport






radiation






or modules


directives


109 / 301


radiation





parameters


therapy










2003/32/EC up to 28.08.2013)














or modules


directives


110 / 301





absorbedNEMKO ASGaustadalleen 30 - PO Box 73 Blindern0314 OSLONorway

0470 Devices manufactured utilizing animal tissue covered by

Directive 2003/32/EC are excluded:

All medical devices, except X-radiation and particle

radiation equipment for diagnostic and therapeutic use


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

AMTAC CERTIFICATION SERVICES LTDDavy Avenue, KnowlhillMilton Keynes MK5 8NLUnited Kingdom


medical devices






devices


measuring function







system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


111 / 301














instruments








anaesthesia










or modules


directives


112 / 301


sterilisation


prostheses


transport






radiation


radiation





parameters


therapy












or modules


directives


113 / 301




2003/32/EC up to 28.08.2013)






absorbedKIWA CERMET ITALIA S.P.A.Via Cadriano, 2340057 - Cadriano di Granarolo (BO)Italy

0476 *MD 0200 - Non-active implants


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III medical devices,

except hip, knee and shoulder joint

replacements.



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III medical devices






or modules


directives


114 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 0300 - Devices for wound care EC declaration of Annex II Excluding class III medical devices






or modules


directives


115 / 301

- *MD 0303 - Other medical devices for wound care conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


116 / 301

instruments assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




with central nervous system


medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


117 / 301

measuring function EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


118 / 301


quality assurance)

EC declaration of


assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





anaesthesia

EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI


and hyperbaric chambers for

oxygen therapy






or modules


directives


119 / 301

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


120 / 301

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


121 / 301


assurance)



transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI


and devices for magnetic

resonance






or modules


directives


122 / 301

assurance)




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


123 / 301


therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





*MDS 7006 - Medical devices in sterile condition Excluding class III medical devices,



with central nervous system; hip,

knee and shoulder joint

replacementsEurofins Product Testing Italy S.r.l.Via Courgnè, 2110156 - TORINO (TO)Italy


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices

EC type-examination

EC verification

Annex III

Annex IV







or modules


directives


124 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 0100 - General non-active, non-implantable EC type-examination Annex III Excluding class III medical devices






or modules


directives


125 / 301

medical devices


EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI


medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



medical devices


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


126 / 301

quality assurance)

EC declaration of


assurance)


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II







or modules


directives


127 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI







or modules


directives


128 / 301

assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




instruments

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


Annex III

Annex IV

Annex II

Annex V







or modules


directives


129 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices






or modules


directives


130 / 301



anaesthesia


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Only class IIa medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


131 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




prostheses

EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


132 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



transport

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




radiation

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


133 / 301


quality assurance)

EC declaration of


assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


and devices for magnetic

resonance




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


134 / 301

quality assurance)

EC declaration of


assurance)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI








*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesECM-ZERTIFIZIERUNGSGESELLSCHAFT 0481 *MD 0100 - General non-active, non-implantable Full quality assurance Annex II






or modules


directives


135 / 301

FÜR MEDIZINPRODUKTE IN EUROPA MBHBismarckstraße 10652066 AACHENGermany

medical devices



system

Production quality

assurance


Annex V

Annex VI


medical devices




system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Annex III: Only infusion sets,

transfusion sets, catheters, tubing

systems for extra-corporal

circulation


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


system

Annex II

Annex V






or modules


directives


136 / 301

- *MD 0106 - Non-active instruments Production quality

assurance


Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

Production quality

assurance


Annex II

Annex III

Annex V

Annex VI

Only stents, implantable catheters,

vascular grafts, occlusion systems




system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


137 / 301

assurance





system

Production quality

assurance


Annex II

Annex V

Annex VI

Only introcular lenses




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


138 / 301



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)

Only devices with existing TSE

Certificate of Suitability for the

starting materials issued by the

European Directorate for the

Qualits of Medicines (EDQM)




absorbedMEDCERT ZERTIFIZIERUNGS- UNDPRÜFUNGSGESELLSCHAFT FÜR DIE

0482 *MD 0100 - General non-active, non-implantable Full quality assurance Annex II






or modules


directives


139 / 301

MEDIZIN GMBHPilatuspool 220355 HAMBURGGermany

medical devices



system

Production quality

assurance


Annex V

Annex VI


medical devices




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices


devices


measuring function




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


140 / 301


medical devices






system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


141 / 301

Production quality

assurance


Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






instruments



system

Production quality

assurance


Annex II

Annex V

Annex VI








anaesthesia



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


142 / 301





sterilisation


prostheses


transport




radiation


radiation





parameters


therapy











or modules


directives


143 / 301





2003/32/EC up to 28.08.2013)









absorbedMDC MEDICAL DEVICE CERTIFICATIONGMBHKriegerstrasse 670191 STUTTGARTGermany



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


144 / 301




parameters


system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy




system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI







or modules


directives


145 / 301

medical devices



system

Production quality

assurance


Annex V

Annex VI


medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


146 / 301

assurance



medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 0200 - Non-active implants Full quality assurance Annex II






or modules


directives


147 / 301

- *MD 0203 - Non-active functional implants system

Production quality

assurance


Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


148 / 301

assurance





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI



prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


149 / 301



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




anaesthesia


system

Production quality

assurance


Annex II

Annex V

Annex VI

except hyperbaric chambers




system

Production quality

assurance


Annex II

Annex V

Annex VI

except external pacemakers and

heart defibrillators




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


150 / 301

Production quality

assurance


Annex VI





2003/32/EC up to 28.08.2013)








absorbedSLG PRÜF UND ZERTIFIZIERUNGS GMBHBurgstädter Strasse 2009232 HartmannsdorfGermany

0494 *MD 1100 - General active medical devices




anaesthesia





sterilisation


prostheses


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


151 / 301


transport




radiation


radiation





parameters


therapy





2006/42/EC on machinerySOCIETE NATIONALE DE CERTIFICATIONET D'HOMOLOGATION S.À.R.L. (SNCH)2a. KalchesbruckL-1852 LUXEMBOURGLuxembourg


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


152 / 301

BSI Group Deutschland GmbHHanauer Landstrasse 11560314 Frankfurt am MainGermany


medical devices






devices


measuring function













instruments




system

Production quality

assurance


Annex II

Annex V

Annex VI







or modules


directives


153 / 301





anaesthesia






sterilisation


prostheses


transport




radiation


radiation





parameters


system

EC type-examination

EC verification

Production quality

assurance


Annex III

Annex IV

Annex V

Annex VI






or modules


directives


154 / 301

therapy










For active medical devices only

*MDS 7006 - Medical devices in sterile conditionVTT Expert Services OyPO Box 345FI-33101 TampereFinland


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


155 / 301


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


156 / 301

assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


157 / 301


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III

*MD 0100 - General non-active, non-implantable EC declaration of Annex II Excluding class III






or modules


directives


158 / 301

medical devices



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


Annex II

Annex V

Excluding class III






or modules


directives


159 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


160 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



sterilisation

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


161 / 301


quality assurance)

EC declaration of


assurance)



prostheses

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



radiation

EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI

Excluding class III






or modules


directives


162 / 301

quality assurance)

EC declaration of


assurance)



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding class III



Excluding class III

*MDS 7006 - Medical devices in sterile condition Including aseptic processing,

ethylene oxide gas sterilisation

(EOG), low temperature steam and

formaldehyde sterilisation, moist






or modules


directives


163 / 301

heat sterilisation (gamma, x-ray,

electron beam), others (need to be

specified)Presafe Denmark A/STuborg Parkvej 8DK-2900 HellerupDenmark


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


164 / 301


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


165 / 301

assurance)


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Excluding orthopaedic implants ref.

2005/50/EEC and bone cement



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


166 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 0300 - Devices for wound care EC declaration of Annex II






or modules


directives


167 / 301

- *MD 0303 - Other medical devices for wound care conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


Annex II

Annex V






or modules


directives


168 / 301

sterilisation assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


169 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)




anaesthesia

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



radiation

EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


170 / 301


quality assurance)

EC declaration of


assurance)



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



parameters

EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


171 / 301

quality assurance)

EC declaration of


assurance)


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





2003/32/EC up to 28.08.2013)

Only products not included in

Directive 2003/32/EC









absorbed







or modules


directives


172 / 301

/utilising software /controlled by softwareCERTIQUALITY S.R.L. - ISTITUTO DICERTIFICAZIONE DELLA QUALITA'Via G. Giardino, 420123 - MILANOItaly


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Exclusion medical devices class III


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


173 / 301


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


*MD 0100 - General non-active, non-implantable EC declaration of Annex II Exclusion medical devices class III






or modules


directives


174 / 301

medical devices



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


175 / 301

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

Annex II

Annex V

Annex VI







or modules


directives


176 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


177 / 301


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

Only those charged with

indipendent power source.





anaesthesia

EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI


indipendent power source.

Exclusion hyperbaric chambers.







or modules


directives


178 / 301

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


indipendent power

source.Exclusion medical devices

class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


indipendent power


class III



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI







or modules


directives


179 / 301

EC declaration of


assurance)




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


indipendent power


class III



parameters

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


indipendent power


class III


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI


indipendent power


class III






or modules


directives


180 / 301


assurance)

*MDS 7006 - Medical devices in sterile condition Exclusion medical devices class IIISGS FIMKO OYP.O. Box 30 (Särkiniementie 3)00211 HELSINKIFinland


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

II: Up to class IIb only


medical devices


devices

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


assurance)

Annex II

Annex VI


*MD 0100 - General non-active, non-implantable EC declaration of Annex II II: Up to class IIb only






or modules


directives


181 / 301

medical devices



assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


Annex II

Annex V







or modules


directives


182 / 301

instruments assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





EC type-examination

EC verification

EC declaration of

Annex III

Annex IV

Annex II

II: Up to class IIb only; III, IV:

Hyperbaric chambers only






or modules


directives


183 / 301

anaesthesia conformity (full quality

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

II: Up to class IIb only; III, IV: Nerve

and muscle stimulator only



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


184 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Dental units and dental patient

chairs only



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


185 / 301

assurance)



prostheses

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Neurological and muscular

rehabilitation devices only



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI




EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI







or modules


directives


186 / 301

quality assurance)

EC declaration of


assurance)



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

II: Up to class IIb only; III, IV: X-ray

devices only



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Magnetic resonance imaging (MRI)

devices only

*MD 1300 - Monitoring devices EC type-examination Annex III II: Up to class IIb only






or modules


directives


187 / 301



EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex IV

Annex II

Annex V

Annex VI



parameters

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI







or modules


directives


188 / 301


assurance)


therapy


EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


Surgical ultrasoud devices only


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI





*MDS 7006 - Medical devices in sterile condition II: Up to class IIb onlyBERLIN CERT PRÜF- UNDZERTIFIZIERSTELLE FÜRMEDIZINPRODUKTE GMBH AN DERTECHNISCHEN UNIVERSITÄT BERLIN




EC type-examination

EC verification

Annex III

Annex IV






or modules


directives


189 / 301

Dovestraße 610587 BERLINGermany




anaesthesia


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

Except hyperbaric chambers




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



EC type-examination

EC verification

Annex III

Annex IV







or modules


directives


190 / 301

- *MD 1106 - Active dental devices system

EC type-examination

EC verification

Production quality

assurance


Annex III

Annex IV

Annex V

Annex VI



sterilisation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



prostheses


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



transport

EC type-examination

EC verification

Annex III

Annex IV



EC type-examination

EC verification

Annex III

Annex IV

*MD 1200 - Devices for imaging Full quality assurance Annex II Except magnetic resonance






or modules


directives


191 / 301


radiation

system

EC type-examination

EC verification

Production quality

assurance


Annex III

Annex IV

Annex V

Annex VI

imaging





system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



parameters


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


therapy


EC type-examination

EC verification

Annex III

Annex IV


therapy


EC type-examination

EC verification

Annex III

Annex IV






or modules


directives


192 / 301



*MDS 7006 - Medical devices in sterile conditionPRÜFSTELLE FÜR MEDIZINPRODUKTEGRAZKopernikusgasse 24/18010 GRAZAustria






anaesthesia






sterilisation


prostheses


transport




radiation


radiation



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


193 / 301



parameters


therapy







medical devices




devices


measuring function






*MDS 7007 - Medical devices utilising micromechanicsNATIONAL EVALUATION CENTER OFQUALITY AND TECHNOLOGY IN HEALTHS.A.- EKAPTYSmyrnis 15


system

Annex II






or modules


directives


194 / 301

165 62 GLYFADAGreece

Implantable and non-implantable orthopaedic materials

and devices

Other implantable devices

Artificial limbs and related components for disabled

Bandages, surgical dressings, medical grade cotton and

other relevant products

dental devices

Disinfectants and antiseptics

Contact lenses and solutions for contact lenses

Absorbable and non-absorbable surgical sutures

- disinfectants and antiseptics#

Sterile and non-sterile single use products

Contraceptives

Contact lenses maintenance products

Absorbable and non-absorbable surgical sutures

Sterile and non-sterile single use products

Contraceptives

EC type-examination Annex III

Only devices mentioned in § B EC verification Annex IV

All medical devices Production quality

assurance


Annex V

Annex VI

THERAPEUTIC GOODS ADMINISTRATIONPO Box 100ACT 2606 WODENAustralia


system

EC type-examination

Annex II

Annex III

Annex IV






or modules


directives


195 / 301

EC verification

Production quality

assurance


Annex V

Annex VI

UL INTERNATIONAL (UK) LTDWonersh House Building C The Guildway OldPortsmouth RoadGuildford GU3 1LRUnited Kingdom

0843 Wound dressings (Class IIa and IIb) EC type-examination

EC verification

Annex III

Annex IV

Gloves for medical use

Urethral catheters

EC verification Annex IV

Active medical devices and their accessories Full quality assurance

system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI

Disinfectants and surgical instruments

Sterile single use medical devices excluding Class III

devices, ophthalmic devices, (class IIa and above) and

implants


system

Production quality

assurance


Annex II

Annex V

Annex VI

Own Brand Labelling of all medical devices which have

existing NB certification via their original manufacturer


system

EC type-examination

EC verification

Production quality

Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


196 / 301

assurance


Non-active Class III cardiac catheters Full quality assurance

system

Annex II

All Dental Devices (Non Active) Full quality assurance

system

Production quality

assurance

Annex II

Annex V

TÜV Rheinland InterCert Muszaki Felügyeletiés Tanúsító Korlátolt Felelosségu TársaságVáci út 48/A-B.H-1132 BudapestHungary


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices

EC declaration of


Annex II

Annex V






or modules


directives


197 / 301


devices

assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI


medical devices


measuring function

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


medical devices


EC declaration of


assurance system)

Annex II

Annex V

Annex VI






or modules


directives


198 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)


medical devices


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


199 / 301


quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


Annex II

Annex V

Annex VI






or modules


directives


200 / 301

quality assurance)

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



instruments

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


201 / 301

EC declaration of


assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

For Annex III. and IV. designation

is limited to infusion pumps. For

Annex II., V., VI. there are no

limitations




anaesthesia

EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V

For Annex III. and IV. designation

is limited to baby incubators,

transportable incubators, infant

warmers, oxygen concentrators.

For Annex II., V., VI. there are no






or modules


directives


202 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI limitations.



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI

Annex III and IV. designation is

limited to defibrillators, nerve and

muscle stimulators,

electroconclusiv therapy

equipments. For Annex II., V., VI.

there are no limitations.



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


limited to high frequency surgery

equipments, suction equipments.


limitations.






or modules


directives


203 / 301



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



sterilisation

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

*MD 1100 - General active medical devices EC declaration of Annex II






or modules


directives


204 / 301


prostheses


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex V

Annex VI



transport

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


limited to electrically operated

hospital beds, operating tables,

wheelchairs (electrically operated).


limitations.




EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI






or modules


directives


205 / 301



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI



radiation

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


limited to high voltage generators

for diagnostic X-ray generators,

Capacitor charged X-ray

generators, Equipments connected

to X-ray equipments. For Annex II.,

V., VI. there are no limitations.



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V

Annex VI






or modules


directives


206 / 301

EC declaration of


assurance)




EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


limited to Electroencephalographs,

Cyclic indirect blood pressure

measurment devices,

Electromyographs, Audiometers.


limitations.



parameters

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex III

Annex IV

Annex II

Annex V

Annex VI


limited to Electrocardiographs,

ECG monitoring equipments,

Transcutane partial pressure

measuring equipments, Direct

blood pressure monitoring

equipments, Pulse oxymeters,

Capnometers, Oxygen monitors.


limitations.


therapy


EC type-examination

EC verification

Annex III

Annex IV


limited to short wave devices for

treatment, Ultrasonic therapy






or modules


directives


207 / 301

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI

equipment, Microwave therapy

equipment, Laser equipment

(diagnostic and therapeutic). For

Annex II., V., VI. there are no

limitations.


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI


therapy



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI







or modules


directives


208 / 301


*MDS 7006 - Medical devices in sterile conditionOrszágos Gógyszerészeti ésÉlelmezés-egészségügyi IntézetEszközmin#sít# és KórháztechnikaiIgazgatóság (National Institute of Pharmacyand Nutrition)Zrínyi u. 3H-1051 BudapestHungary



radiation

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



radiation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



parameters


system

EC type-examination

EC verification

Production quality

Annex II

Annex III

Annex IV

Annex V






or modules


directives


209 / 301

assurance


Annex VI


therapy


EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V


therapy



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


therapy



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices




system

EC type-examination

EC verification

Production quality

Annex II

Annex III

Annex IV

Annex V






or modules


directives


210 / 301

assurance


Annex VI


medical devices




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices


devices


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices


measuring function


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices



system

EC type-examination

Annex II

Annex III

Annex IV






or modules


directives


211 / 301

EC verification

Production quality

assurance


Annex V

Annex VI


medical devices



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex III

Annex IV

Annex II

Annex V

Annex VI

Annex III. and IV. designation

excluding materials of desinfecting,

cleaning and rinsing . For Annex

II., V., VI. there are no limitations.






or modules


directives


212 / 301


assurance)


medical devices




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



instruments

EC type-examination

EC verification

Annex III

Annex IV



EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex II

Annex V

Annex VI



EC type-examination

EC verification

Annex III

Annex IV





system

EC type-examination

EC verification

Annex II

Annex III

Annex IV

Annex V






or modules


directives


213 / 301

Production quality

assurance


Annex VI




anaesthesia


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

Annex II

Annex III






or modules


directives


214 / 301

EC type-examination

EC verification

Production quality

assurance


Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



sterilisation


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



prostheses


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


215 / 301



transport


system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI





system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



EC type-examination

EC verification

EC declaration of


assurance system)

Annex III

Annex IV

Annex II

Annex V






or modules


directives


216 / 301

EC declaration of


quality assurance)



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex IV

Annex II

Annex V



EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex III

Annex IV

Annex II

Annex V



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V



EC declaration of


assurance system)

Annex II

Annex V






or modules


directives


217 / 301

EC declaration of


quality assurance)

EC declaration of


assurance)

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI



thereof

EC type-examination

EC verification

EC declaration of


assurance system)

EC declaration of


Annex III

Annex IV

Annex II

Annex V

Annex VI






or modules


directives


218 / 301

quality assurance)

EC declaration of


assurance)



Designation excludes products

under the scope MD 0201



2003/32/EC up to 28.08.2013)

Designation excludes products

related 2003/32/EC BSE/TSE field.

Designation includes Annex 2 and

5.






absorbed


/utilising software /controlled by softwareELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV,s.p.Pod Lisem 129171 02 PRAHA 71 - TrojaCzech Republic


medical devices






devices



system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


219 / 301

measuring function



















instruments








system

EC type-examination

EC verification

Annex II

Annex III

Annex IV

Annex V






or modules


directives


220 / 301


anaesthesia






sterilisation


prostheses


transport






radiation


radiation





parameters


therapy

Production quality

assurance


Annex VI






or modules


directives


221 / 301










2003/32/EC up to 28.08.2013)

except application of Commission

Regulation 722/2012






absorbedINSTITUT PRO TESTOVÁNI A CERTIFIKACI,a. s.T. Bati 299Louky, 76302 ZLINCzech Republic


medical devices






system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


medical devices


devices


system

EC verification

Production quality

Annex II

Annex IV

Annex V






or modules


directives


222 / 301


measuring function

assurance


Annex VI


medical devices









system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI




system

EC type-examination

EC verification

Production quality

assurance

Annex II

Annex III

Annex IV

Annex V











system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


directives


223 / 301


instruments








anaesthesia






sterilisation



prostheses


transport


system

EC verification

Production quality

assurance


Annex II

Annex IV

Annex V

Annex VI






system

EC type-examination

EC verification

Annex II

Annex III

Annex IV

Annex V






or modules


directives


224 / 301



radiation

Production quality

assurance


Annex VI



radiation


system

EC verification

Production quality

assurance


Annex II

Annex IV

Annex V

Annex VI





parameters


therapy



system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI


therapy



system

EC verification

Production quality

assurance


Annex II

Annex IV

Annex V

Annex VI


therapy




system

EC type-examination

EC verification

Annex II

Annex III

Annex IV






or modules


directives


225 / 301

therapy (lithotripsy) Production quality

assurance


Annex V

Annex VI





2003/32/EC up to 28.08.2013)













absorbedSCHWEIZERISCHE VEREINIGUNG FÜRQUALITÄTS- UND MANAGEMENTSYSTEMEBernstrasse 1033052 ZOLLIKOFENSwitzerland


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI







or modules


directives


226 / 301

medical devices


devices

system

Production quality

assurance


Annex V

Annex VI


medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI


medical devices



system

Production quality

Annex II

Annex V

Annex VI






or modules


directives


227 / 301

emergency and intensive care assurance





system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


228 / 301




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI

excluding heart-lung machine




system

Annex II

Annex V

only respiratory devices






or modules


directives


229 / 301


anaesthesia

Production quality

assurance


Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance

Annex II

Annex V

Annex VI






or modules


directives


230 / 301




prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI



radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI


therapy




system

Production quality

assurance


Annex II

Annex V

Annex VI



*MDS 7006 - Medical devices in sterile conditionQS Zürich AGPostfach 6335CH-8050 ZürichSwitzerland


medical devices



system

Production quality

Annex II

Annex V

Single use medical products and

reusable medical instruments






or modules


directives


231 / 301

emergency and intensive care assurance


Annex VI


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI




medical devices


devices


system

Production quality

assurance


Annex II

Annex V

Annex VI




medical devices


measuring function


system

Production quality

assurance


Annex II

Annex V

Annex VI

Reusable medical instruments


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI




medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI






or modules


directives


232 / 301


medical devices



system

Production quality

assurance


Annex II

Annex V

Annex VI

Single use medical products


medical devices




system

Production quality

assurance


Annex II

Annex V

Annex VI






system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Annex II

Annex V






or modules


directives


233 / 301

Production quality

assurance


Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI



instruments


system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




system

Production quality

assurance


Annex II

Annex V

Annex VI




anaesthesia


system

Production quality

assurance

Annex II

Annex V

Annex VI

Measuring equipment as

accessories to medical devices






or modules


directives


234 / 301





system

Production quality

assurance


Annex II

Annex V

Annex VI






system

Production quality

assurance


Annex II

Annex V

Annex VI



sterilisation


system

Production quality

assurance


Annex II

Annex V

Annex VI





prostheses


system

Production quality

assurance


Annex II

Annex V

Annex VI



transport


system

Production quality

assurance


Annex II

Annex V

Annex VI

*MD 1200 - Devices for imaging Full quality assurance Annex II Measuring equipment as






or modules


directives


235 / 301


radiation

system

Production quality

assurance


Annex V

Annex VI




radiation


system

Production quality

assurance


Annex II

Annex V

Annex VI





system

Production quality

assurance


Annex II

Annex V

Annex VI




therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI




therapy



system

Production quality

assurance


Annex II

Annex V

Annex VI




therapy



system

Production quality

Annex II

Annex V

Annex VI








or modules


directives


236 / 301

assurance









absorbedEVPU a.s.Trencianska 19018 51 NOVA DUBNICASlovakia


medical devices






devices


measuring function









system

EC type-examination

EC verification

Production quality

assurance


Annex II

Annex III

Annex IV

Annex V

Annex VI






or modules


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237 / 301







system

EC type-examination

EC verification

Production quality

assurance

Annex II

Annex III

Annex IV

Annex V







instruments








anaesthesia







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EC type-examination

EC verification

Production quality

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Annex II

Annex III

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Annex VI






or modules


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238 / 301

sterilisation


prostheses


transport






radiation


radiation





parameters


therapy













or modules


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239 / 301













absorbedBUREAU VERITAS ITALIA S.P.A.Via Miramare, 1520126 - MILANOItaly


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anaesthesia

EC declaration of


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EC declaration of


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hyperbaric chambers for oxygen

therapy and medical gas pipeline

systems



EC declaration of


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EC declaration of


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*MD 1100 - General active medical devices EC declaration of Annex II Excluding class III medical devices






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assurance system)

EC declaration of


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EC declaration of


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Annex V

Annex VI



EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesPOLSKIE CENTRUM BADAN ICERTYFIKACJI S.A.

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SGS Belgium NVNoorderlaan 87BE-2030 AntwerpenBelgium


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EC declaration of


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medical devices



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medical devices



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EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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Annex II

Annex V

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EC declaration of


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EC declaration of


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Annex V

Annex VI




EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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- *MD 1401 - Devices utilising ionizing radiation assurance system)

EC declaration of


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EC declaration of


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Annex VI


therapy


EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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*MDS 7006 - Medical devices in sterile condition No class III medical devices.TURKISH STANDARDS INSTITUTION (TSE)Necatibey Cad. No. 112, 06100 BakanliklarAnkaraTurkey


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EC type-examination

EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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Annex II

Annex V

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EC type-examination

EC declaration of


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absorbedDARE!! CertificationsVijzelmolenlaan 7NL-3447 GX WoerdenNetherlands




EC type-examination

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Annex III

Annex IV

Limited to devices for infusion.

Limited to non sterile class Im, IIa

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EC type-examination

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and IIb devicesTUV Rheinland Italia SRLVia Mattei, 320010 - Pogliano Milanese (MI)Italy


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EC declaration of


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EC declaration of


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EC declaration of


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EC declaration of


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Annex III

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EC declaration of


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Annex IV

Annex II

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*MD 1400 - Devices for radiation therapy and thermo EC verification Annex IV Excluding class III medical devices






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EC declaration of


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EC declaration of


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*MDS 7006 - Medical devices in sterile condition Excluding class III medical devicesSGS Hungária Minoségellenorzo, Kereskedelmiés Szolgáltató Kft.Sirály utca 4.H-1124 BudapestHungary

1979 Active medical devices

Non-active medical devices, except soft tissue implants,

cardio vascular implants and dental materials


system

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Annex II

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Kiwa Meyer Belgelendirme Hizmetleri A.#.Tepeören Mevkii Ankara Asfalt# Maret Arkas#ITOSB 9. Cadde No: 15 TuzlaIstanbulTurkey



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EC declaration of


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Annex II

Annex V






or modules


directives


294 / 301


quality assurance)



EC declaration of


assurance system)

EC declaration of


quality assurance)

Annex II

Annex V





2003/32/EC up to 28.08.2013)









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EC declaration of


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EC declaration of


quality assurance)

Annex II

Annex V






or modules


directives


295 / 301

medical devices






devices


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instruments








or modules


directives


296 / 301


medical devices







anaesthesia





sterilisation


prostheses


transport





thereof










or modules


directives


297 / 301

therapy








*MDS 7006 - Medical devices in sterile condition Including aseptic processing,

ethylene oxide gas sterilisation

(EOG), low temperature steam and

formaldehyde sterilisation, moist

heat sterilisation, radiation

sterilisation (gamma, x-ray,

electron beam), others (need to be

specified)



absorbed


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radiation





EC declaration of


assurance system)

EC declaration of


quality assurance)

EC declaration of

Annex II

Annex V

Annex VI






or modules


directives


298 / 301

parameters


therapy



medical devices






devices


measuring function















assurance)






or modules


directives


299 / 301






instruments





sterilisation


prostheses






anaesthesia






medical devices







or modules


directives


300 / 301



regarding Annex II, V, VI




*MDS 7006 - Medical devices in sterile condition regarding Annex II, V, VI



absorbed










or modules


directives


301 / 301

93/42/eec medical devices - consultants industrie ......*mds 7002 - medical devices utilising...

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