mdr presentation april 2018 monisha phillips [repaired]€¦ · microsoft powerpoint - mdr...
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29
MDR ClassificationAnnex VIII
32
Classification Rules – MDR, Annex VIII
MDR MDD
Rules 1 – 4: Non-invasive devices
Rules 5 – 8 : Invasive devices
Rules 9 – 13 : Active Devices
Rules 14 – 22 : Special rules
Rules 1 – 4 : Non-invasive devices
Rules 5 – 8 : Invasive devices
Rules 9 – 12 : Active devices
Rules 13 – 18 : Special rules
33
Rules 1 - 4: Non-invasive devices (in comparison with MDD)
Rule 1
• No change
Rule 2
• Addition of “cellsand tissues” to theexisting language
• Blood bags movedto MDR Rule 2from Rule 18 ofMDD
Rule 3
• Addition of humantissues and cells toblood, body liquidsand other liquids
• Intended forimplantation oradministration vsIntended forinfusion in MDD
• Inclusion of organstorage solutions,IVF media into therule which areclass III
Rule 4
• Addition of injuredmucousmembrane toinjured skin
• Replacement of‘wounds’ withinjuries to skin
• Also coversinvasive devicesthat come intocontact withinjured mucousmembrane
34
Rules 5 – 8: Invasive devices (in comparison with MDD/AIMD)
Rule 5
• No change –clarifications only
Rule 6
• All devicesintendedspecifically fordirect contact withheart or centralcirculatory systemnow class IIIsimilar to devicesin contact withcentral nervoussystem
Rule 7
• All devicesintendedspecifically fordirect contact withheart or centralcirculatory systemnow class IIIsimilar to devicesin contact withcentral nervoussystem
Rule 8• AIMD devices and
accessories are classIII
• Breast implants andsurgical meshes areclass III
• Total and partialjoint replacementsare class III
• Spinal discreplacementimplants orimplantable devicesthat come intocontact with spinalcolumn are class IIIwith someexceptions (screws,wedges, plates andinstruments)
35
Rules 9 – 13: Active Devices (in comparison with MDD/AIMD)
Rule 9• Addition of active
devices intended toemit ionizing radiationfor therapeuticpurposes, includingdevices which controlor monitor suchdevices, or whichdirectly influence theirperformance, areclassified as class IIb.
• Addition of activedevices that areintended forcontrolling, monitoringor directly influencingthe performance ofactive implantabledevices are classifiedas class III.
Rule 10
• Addition of‘monitoring’ todiagnosis;
• Active devicesintended fordiagnosis inclinical situationswhere the patientis in immediatedanger as classIIb
Rule 11
• New rule onsoftware
• Classificationsrange from classIII – class I
Rule 12
• Rule 11 in MDD
• No change
Rule 13
• Rule 12 in MDD
• No change
36
Rules 14 – 18: Special rules
Rule 14(Devices withmedicinalsubstances)
• Rule 13 in MDD
• Clarification thatmedicinal productcan be derivedfrom human bloodor plasma
• “Liable to act”taken out
Rule 15(Contraceptivedevices, Devicesfor prevention oftransmission ofSTDs)
• Rule 14 in MDD
• No change
Rule 16(Disinfectants,sterilizers)
• Rule 15 in MDD
• Addition ofsterilisers todisinfectants
• Disinfectants orsterilisers becomeIIb only if theyare used forinvasive devicesand as the endpoint ofprocessing
Rule 17(Devices forrecording x-raydiagnostic images)
• Rule 16 in MDD
• No change –language clarified
Rule 18(Devices utilizinghuman or animalderivatives)
• Rule 17 in MDD
• Addition of cells (totissues)
• Addition of humanorigin cells and tissuesor derivatives
• The exception aboutcontact with intactskin only, applies onlyto animal tissue anddoes not apply tohuman tissues or cells
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Rules 19 – 22: Special rules
Rule 19(Devices incorporatingor consisting ofnanomaterials)
• New rule
• Classifications from IIIto IIa based on potentialfor internal exposure
Rule 20(Body-orifice invasivedevices intended toadminister medicines byinhalation)
• New rule
• Classification IIa or IIb
• IIb if they impact thesafety and performanceof the medicine orintended to treat life-threatening conditions
Rule 21(Devices consisting ofsubstances andintroduced into thebody via body orifice orskin and that areabsorbed by or locallydispersed)
• New rule
• Classification from IIa toIII based on where theyare used and whetherthey or their products ofmetabolism areabsorbed
Rule 22(Active therapeuticdevice with anintegrated orincorporated diagnosticfunction)
• New rule
• Class III
• Only applies if suchdevices significantlydetermine the patientmanagement
• Closed loop systems orautomated externaldefibrillators
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Conformity Assessment ProceduresAnnex IX, X, XI
39
Classification & Conformity Assessment – MDD
Competent Authority Assessment
Notified Body Conformity Assessment
Self-Certification
Class III
Class IIb
Risk
Class IIa
Class Im /Is
Class I
Custom Made
40
Classification & Conformity Assessment – MDR
Commission Assessment
Competent Authority Assessment
Notified Body Conformity Assessment
Self-Certification
Class III Custom Made
Implants
Class Ir
Class III ImplantsClass IIb active – administer
medicine
Class III
Class IIb
Risk
Class IIa
Class Im /Is
Class I
Custom Made
Class IIb Implants
41
Regulation EU 2017/745 – Conformity Assessment
Qua
lity
Man
agem
ent
Syst
em
Mic
robi
olog
y
Tech
nica
lD
ocum
enta
tion
Una
nnou
nced
Aud
it
Clin
ical
Eva
luat
ion
Con
sulta
tion
Proc
edur
e (C
ECP)
(A
rtic
le 5
4)
2001
/83/
ECEC
/726
/200
420
04/2
3/EC
EU 7
22/2
012
PSU
R (
Art
icle
86)
(*Ann
ual)
SSCP
(Art
icle
32)
Class III Implants 5 years *
Class III 5 years *
Class IIb Active Intended to administer and/orremove Medicines from the body
Sample pergroup
5 years * notsubmitted to NB
Class IIb Implants 5 years *
Sutures, staples, dental fillings, dental braces,tooth crowns, screws, wedges, plates, wires, pinsclips, connectors
Sample pergroup
5years
Class IIb Sample pergroup
5years * notsubmitted to NB
Class IIa Sample percategory
5years not
submitted to NB
42
Regulation EU 2017/745 – Conformity Assessment
Qua
lity
Man
agem
ent
Syst
em
Mic
robi
olog
y
Tech
nica
lD
ocum
enta
tion
Una
nnou
nced
Aud
it
Clin
ical
Eva
luat
ion
Con
sulta
tion
Proc
edur
e (C
ECP)
(A
rtic
le 5
4)
2001
/83/
ECEC
/726
/200
420
04/2
3/EC
EU 7
22/2
012
PSU
R (
Art
icle
86)
(*Ann
ual)
SSCP
(Art
icle
32)
Class Is, Im, Ir 5years
Class I
Class III Custom Made Implants 5years
Custom Made
Procedure Packs (Article 22) 5years
Suppliers, Subcontractors *depends
on certificationheld
*depends
on certificationheld
5years
EU Authorised Representatives,Importers, Distributors (Article 16)
*impactsterile barrier,translate,repackage
*impactsterile barrier,translate,repackage
5years
Drug Delivery Products (Article 117) *conformitywith SPRs