classification of medical devices - tuev-sued.de. non invasive devices annex vii, chapter iii, rule...

Classification of medical devices medical devices MDR Annex VII

Norbert Stuiber

TÜV SÜD Product Service GmbH Slide 1Classification of medical devices 6-Jul-16

Overview

f f

1 Introduction & classification process

Note: The EU’s new regulations have not been finalised, and the information contained herein is subject to change.

1 Introduction & classification process

2 Non Invasive Devices

3 Invasive Devices

4 Active Devices

5 Special Rules


p

1 Introduction and classification process

MDD classificationMDD classification Rules Annex IX of the MDD

MEDDEV Guidelines e.g.2. 4/1, 2.1/6

Borderline ManualBorderline Manual

MDD amendments e.g. COMMISSION DIRECTIVE 2003/12/EC

TÜV SÜD Slide 3Classification of medical devices 6-Jul-16

1 Introduction and classification process

Changes in the classification rulesChanges in the classification rules Changes in the classification rules of medical devices

might lead to reclassification of certain medical devices.

Manufacturers shall check, if the respective classification rule is still applicable.

In case of disputes regarding the classification ofmedical devices, different scenarios may occur


1. Introduction & Classification Process

MDDManufacturer

ClassificationClassification

Notified Body

Not acceptedAccepted Dispute

Competent Authority to which the


notified body is subjected

1. Introduction & Classification Process Art. 41

Manufacturer (registered place of business) and notified body in the same Member State

Manufacturer (registered place of business) and notified body in different Member States

Manufacturer

Classification

NB

AcceptedDispute Accepted DisputeAcceptedDispute Accepted Dispute

Competent Competent Consultation with competent p

authority of the Member State of the manufacturer

(address of

Notification to MDCG

pauthority of the

Member State of the manufacturer

(address of

competent authority of the Member State

which designated the


(business)

(business) designated the

notified body

2. Non invasive Devices Annex VII, Chapter III, Rule 1-4

R l 2Rule 2Channeling or

storing for eventual infusion eventual infusion

administration

I

For use with blood, other body fluids, cellsorgans tissues

May be connected to an active medical device in

Class IIa or higherBlood bags

organs, tissues Class IIa or higher

IIa IIa IIb

TÜV SÜD Product Service GmbH Slide 716-07-06

IIa IIa IIb


R l 3Rule 3Modifying biological or chemical

composition of blood, body liquids other liquids intended forliquids, other liquids intended forimplantation or administration

IIb

Only filtration , centrifugation or

exchange of gas or heat

Substances intended to be used in vitro in direct contact with

human cells/tissues/organs or with human embryos before exchange of gas or heat

IIa

with human embryos before implantation/administration

III


IIa III


Rule 4In contact with injured skin or

mucous membrane

(mechanical barrier, ( ,compression, absorption)

II

Intended for injuries to skin which have breached the

dermis or mucous b d h l l b

Intended to manage the micro-environment of

injured skin or mucous membrane and heal only by secondary intent

jmembrane


IIb IIa


ConclusionsConclusions Different classification rules, without changing the class

Coverage of IVF / Tissue Engineering as Class III plus e.g. antibodies of human/synthetic origin


3. Invasive Devices Annex VII, Chapter III, Rule 5-8

Rule 6 / 7 (surgically invasive devices for transient/ short term use):

Devices intended specifically for use in direct contact with the heart or central circulatory system are class III, regardless of duration of application



Rule 6S i ll i i Surgically invasive – Transient use

IIa

Control/diagnose/monitor/ correct a defect of

Used in direct contact with central nervous Supply energy Reusable

Biological effect

Intended to administer r/ correct a defect of

heart or central circulatory system

through direct contact

with central nervous system or with heart

or central circulatory system

Supply energy /ionizing radiation

Reusable surgical

instrument

effect –mainly or wholled

absorbed

administer medicinal products

in a potential hazardous manner


III IIII IIb IIb IIb


Rule 7Rule 7Surgically invasive – Short-term use

IIa

Control/diagnose/ monitor / correct a

defect of heart or centralcirculatory system

Used in direct contactwith central nervoussystem or with heart

or central circulatory

Supplyenergy/ionizin

g radiation

Undergo chemicalchange in body or

adminstermedicines (NOT in

Biological effect –

mainly/wholly absorbed y y

through direct contacty

system

III

g(teeth) y absorbed

IIIIIb IIb III


III IIIIIb IIb III


Rule 8Rule 8Surgically invasive long-term use and

implantable devices

IIb

Total/Partial

Breast implants

and To be placed in teeth

Undergo chemical change in

body (NOT in

Used in direct contact with

heart or central

Biological effect or wholly or

Active implantable medical devices

and their

Total/Partial joint/spinal disc

replacements and implantable devices in contact with the surgical

meshes

in teeth y (teeth) or

administer medicines

circulatory / nervous system

ymainly

absorbed

and their accessories

in contact with the spinal column(NOT ancillary components )


IIa IIIIII III III III III


Conclusions

Some devices will have to be reclassified e.g.:

Devices intended specifically for use in direct contact with the heart or central icirculatory system are class III (e.g. icirculatory system are class III (e.g. catheters which were not falling in MDD rule 6/7 )

Active implantable devices and their accessories are class III

Total, partial joints, spinal disc replacements and implantable devices in


contact with the spinal column are class III

4. Active Devices Annex VII, Chapter III, Rule 9-12

Rule 9Active therapeutic

devices intended toadminster or

exchange energyexchange energy

IIa

Intended to emit Intended to

control/monitor or toinfluence directly the

performance of a class

Administer orexchange energy in

potentially

Intended to emit ionizing radiation for

therapeutic purposes, including devices which control or monitor such

Active devices intended for controlling,

monitoring, or directly influencing the performance of a class

IIb active therapeuticdevice

potentiallyhazardous way

control or monitor such devices, or which

directly influence their performance

influencing the performance of active

implantable devices


IIb IIb IIb III


Rule 10Active devices for diagnosis and

monitoring. If intended to supply energy absorbed by the human body, to image

in vivo distribution of radio pharmaceuticals, or for direct diagnosis

or monitoring of vital physiological or monitoring of vital physiological processes

IIa

Specifically intended for monitoring vital physiological parameters where variations could result in immediate danger of the patient or to

Devices intended to illuminate the

patient's body (in g pdiagnose clinical situations where the

patient is in immediate danger

p y (the visible spectrum)


I IIb


Rule 10aSoftwareSoftware

II

Software intended to Intended to provide information which is used to take decisions monitor physiological

processes

IIa

which is used to take decisions with diagnosis or therapeutic

purposes

IIaIIa

If the decision may directly or If the decision may directly or

IIa

Software intended to monitor If the decision may directly or indirectly cause death or

irreversible deterioration of the state of health

If the decision may directly or indirectly cause deterioration of the state of health or a surgical

intervention

physiological parameters, where the nature of variations

could result in immediate danger to the patient


IIIIIb

g p

IIb

5. Special rules Annex VII, Chapter III, Rule 13-23

Rule 17Devices manufactured

utilizing tissues or cells ofutilizing tissues or cells ofhuman or animal origin ortheir derivatives which arenot viable or rendered not

Rule 19Devices incorporating or

consisting of nanomaterialsviable

III

Devices manufactured utilizing ti ll f i l i i High/medium L t ti l f Negligible potential tissues or cells of animal origin or their derivatives, which are non-

viable or rendered non-viable that are intended to come into contact

ith i t t ki l

High/medium potential for internal

exposure

Low potential for internal exposure

Negligible potential for internal exposure

with intact skin only

To be classified according to other

III IIb IIa


To be classified according to other applicable rules


Rule 21Devices that are composed of substances intended t b i t d d i t th b d i b d ifi to be introduced into the body via a body orifice, or applied on skin and that are absorbed by or locally

dispersed in the human body

The device, or its products of metabolism,

are systemically

The device achieves its intended purpose in the

stomach or lower

Device applied on skinor

in the nasal or oral cavity as far are systemically absorbed by the human body in order to achieve

the intended purpose

gastrointestinal tract and the device or its products of

metabolism are systemically absorbed by the human body

in the nasal or oral cavity as far as pharynx and achieving the

intended purpose on these cavities

All other cases

III IIa IIbIII



Rule 22i i d i ith t t

Rule 23Active therapeutic devices with an

integrated or incorporated invasive devices with respect to body orifices, other than

surgically invasive devices, which are intended to administer

di i l d t b i h l ti

integrated or incorporated diagnostic function, which

significantly determinates the patient management by the device such as closed loop medicinal products by inhalation device, such as closed loop

systems or automated external defibrillators.

IIa III

Essential impact on the efficacy and safety of the administered medicinal

product , including the devices intended p gto treat life threatening conditions

IIb


IIb

5. Special rules: Annex VII, Chapter III, Rule 13-23

C l iConclusions Nanomaterials shall be taken into consideration for the classification New wording “human origin” in addition to the already existing “animal origin” Open points regarding some rules (e.g. #10a, 21)

Early preparation is key. We urge manufacturers to check if the devices have to be reclassified according to the new medical device regulation.


Stay informed about the expected changes and prepare for transition

Prepare for the transitionPrepare for the transition We are closely following the regulation

developments and will provide updates to developments, and will provide updates to medical devices manufacturers to help them stay informed about the transition.

For the latest information, visit the following webpages:

Medical Device Regulation: www.tuv-sud.com/mdr

In Vitro Diagnostic Device Regulation:www.tuv-sud.com/ivdr


Contact us today for one-stop quality, safety and sustainability solutions. www.tuv-sud.com/medicaldevice

di ld i @t [email protected]

TÜV SÜD Product Service GmbH Slide 246-Jul-16 Classification of medical devices

classification of medical devices - tuev-sued.de. non invasive devices annex vii, chapter iii, rule...

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