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Page 1: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

29

MDR ClassificationAnnex VIII

Page 2: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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

Page 3: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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

Page 4: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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)

Page 5: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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

Page 6: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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

Page 7: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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

Page 8: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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Conformity Assessment ProceduresAnnex IX, X, XI

Page 9: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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

Page 10: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

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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

Page 11: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

41

Regulation EU 2017/745 – Conformity Assessment

Qua

lity

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agem

ent

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em

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robi

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tion

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edur

e (C

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(A

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le 5

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2001

/83/

ECEC

/726

/200

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3/EC

EU 7

22/2

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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

Page 12: MDR Presentation April 2018 Monisha Phillips [Repaired]€¦ · Microsoft PowerPoint - MDR Presentation April 2018 Monisha Phillips [Repaired] Author: wongjo Created Date: 8/20/2018

42

Regulation EU 2017/745 – Conformity Assessment

Qua

lity

Man

agem

ent

Syst

em

Mic

robi

olog

y

Tech

nica

lD

ocum

enta

tion

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nnou

nced

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ical

Eva

luat

ion

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sulta

tion

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edur

e (C

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(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