medical devices regulation

Copyright © 2021 BSI. All rights reservedCopyright © 2021 BSI. All rights reserved

Notified Body UpdateTransition to MDR / IVDR NBs

Tony RizzoRegulatory Services (Medical Devices), BSI21 September 2021

Copyright © 2021 BSI. All rights reserved

Medical Devices Regulation


1. MDR / IVDR Transition Timelines2. MDR / IVDR Transition Process for NBs3. Availability of NBs

2

Agenda


3


MDR / IVDR Transition Timelines



MDR Transition (Article 120)

Adoption of MDR05 May 2017

Entry in to Force 25 May 2017

NBs designationunder MDR

Original -> PostponedDate of Application

26 May 2020 26 May 2021

MDD/AIMDD certificate validity(4 years )

MDD/AIMDD certificates can be issued/re-issued/renewed

MDR certificates

Transition period3 years

MDD/AIMDD Annex IV certificates void on 27 May 2022

No more « makingavailable or putting into

service » of devicescovered by MDD/AIMDD

certificates

MDD/AIMDD certificates void

27 May 2024

27 May 2025

NBs can apply for designation26 Nov 2017


IVDR Transition (Article 110)


05 May 2017Adoption of IVDR


NBs designationunder IVDR

Date of Application26 May 2022

IVDD certificatevalidity (2 years )

IVDD certificates can be issued/re-issued/renewed

IVDR certificates


No more « makingavailable or putting

into service » of devices covered by IVDD certificates

IVDD certificates void27 May 2024

27 May 2025



6


Notified Bodies Transition (Designation) Process


NB Designation Process

Source NBM-046-187


Tightening of NB oversight began a few years before MDR

8

• 24 September 2013: Commission Recommendation 2013/473/EU• Consistency on Product and QMS assessments• Responsibilities of legal manufacturer over subcontractors/suppliers• Unannounced audits

• Joint Assessments of NBs under MDD, AIMD, IVDD• May 2017: Medtech Insight: “More EU NBs Bite the Dust . . .”• Numbers

• & Scopes Reduced:

Directive/Year 2013 2016 2017MDD 75 58 55AIMD 16 14 13IVDD 23 21 22Total 114 93 90


Status of NB Applications under MDR / IVDR - October 2018

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Progress MDR IVDR TotalApplications received 26 7 33Preliminary assessment reports 20 5 25Witness assessments - done 10 3 13Witness assessments - scheduled 10 2 12CAPA plans received 6Joint Assessment Team Opinion issued 1Designating authority final report 0Listed on NANDO 0


Status of NB Applications under MDR / IVDR - May 2021

10

Progress MDR IVDR TotalApplications received 54 -4 18 -2 66Preliminary assessment reports 42 -1 12 52Witness assessments - done 40 10 50Witness assessments - scheduled 1 2 3CAPA plans received 29 6 35Joint Assessment Team Opinion issued 23 5 28Designating authority final report 23 5 28Listed on NANDO 20 4 24


Status of NB Applications under MDR / IVDR - May 2021

11


0

5

10

15

20

25

30

Directives Regulation

NB Requirements (Chapter IV, Annex VII)

Number of Pages


NB Requirements – Basic Requirements

MDD - Article 161 Page

• Notification• Certificate status notification• Provide info when requested• Follow Annex IV requirements

MDR – Chapter IV16 Articles - 10 Pages

• Authorities responsible for NBs• Requirements about NBs, incl permanent availability

tech & scientific personnel, • Subsidiaries, subcontracting• Application for designation• Assessment of NBs • Experts assignment to JAT for assessments• Language requirements• Designation/notification procedure


NB Requirements – Basic Requirements

MDD - Article 161 Page

• Notification• Certificate status notification• Provide info when requested• Follow Annex IV requirements

MDR – Chapter IV16 Articles - 10 Pages

• Authorities responsible for NBs• Requirements about NBs, incl

permanent availability tech & scientific personnel,

• Subsidiaries, subcontracting• Application for designation• Assessment of NBs • Experts assignment to JAT for

assessments• Language requirements• Designation/notification procedure

• ID#, list of NBs• Monitoring and re-assessment of NBs• Review of NB assessment of technical

and clinical evaluation documentation• Changes to designation/notifications• Challenge to competence of NBs• Peer review/exchange of experience

between authorities responsible for NBs

• Coordination• List of standard fees


NB Requirements – Criteria

MDD - Annex XI1 Page – 8 Paragraphs

2 Shalls, 8 Musts• No relationship w/ manufacturers, users, A. Reps• Integrity & Competence• Capability for designated Conformity Routes• Training, knowledge, records• Impartiality• Insurance• Confidentiality

MDR – Annex VII17 Pages - 104 Paragraphs not counting

multiple bullets within paragraphs67 Shalls, 0 Musts

• Organizational & General• Legal status, organizational structure • Independence & Impartiality• Confidentiality• Insurance• Financial• Coordination activities, Best practices


NB Requirements – Criteria

MDD - Annex XI1 Page – 8 Paragraphs

2 Shalls, 8 Musts• No relationship w/

manufacturers, users, A. Reps• Integrity & Competence• Capability for designated

Conformity Routes• Training, knowledge, records• Impartiality• Insurance• Confidentiality

MDR – Annex VII17 Pages - 104 Paragraphs

67 Shalls, 0 Musts• Organizational & General• Legal status, organizational structure • Independence & Impartiality• Confidentiality• Insurance• Financial• Coordination activities, Best practices

• Quality Management Requirements• Resource Requirements• Personnel - Extensive (functions- clinical,

product, QMS, review/decision)• Process Requirements• Pre-application, Application review• Resource allocation• Conformity assessment – QMS, Product,

Pre-clinical, Clinical• Reporting / Review / Decisions / Changes• Surveillances & Post-certification

monitoring• Recertification


Implementing Act - Codes (EU) 2017/2185

17

MDD, AIMDD, IVDD NBOG Codes

Device Groupings (Vertical Codes – MD 1XXX)

Eg MD 1106 - Active Dental DevicesAIMD 0101 – AIMDs for stimulation/inhibition

Specifics of Devices (Horizontal Codes – MDS 70XX)

Eg MDS 7002 – Devices utilizing animal tissuesMDS 7006 – Devices in sterile condition

MDR, IVDR NBOG Codes

Device Groupings (Vertical codes)

MDA 0XXX - Active implantable & Active non-implantable MDN 1XXX - Non-active Implantable & non-implantable

Specifics of Devices (Horizontal codes – MDS 10XX)

Technology or Process codes(QMS Audit codes – MDT 20XX)

N = 30 codes (IVDD)

N = 58 codes (MDD, AIMD)

N = 71 codes (MDR)

N = 80 codes (IVR)


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Availability of Notified Bodies


Designated Notified Bodies (16 September 2021)

19

MDR = 24

IVDR = 6



MDR Transition Timeline

Adoption of MDR05 May 2017


NBs designationunder MDR

Original -> PostponedDate of Application

26 May 2020 26 May 2021

MDD/AIMDD certificate validity(4 years )

MDD/AIMDD certificates can be issued/re-issued/renewed

MDR certificates


No more « makingavailable or putting into

service » of devicescovered by MDD/AIMDD

certificates

MDD/AIMDD certificates void

27 May 2024

27 May 2025


We are here

Countdown


Directive Certificates

21


22

Reconciliation of time left to certificates expiring


23

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