3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation
Medical Devices Regulation
Transcript of Medical Devices Regulation
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Notified Body UpdateTransition to MDR / IVDR NBs
Tony RizzoRegulatory Services (Medical Devices), BSI21 September 2021
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Medical Devices Regulation
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1. MDR / IVDR Transition Timelines2. MDR / IVDR Transition Process for NBs3. Availability of NBs
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Agenda
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MDR / IVDR Transition Timelines
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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
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IVDR Transition (Article 110)
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05 May 2017Adoption of IVDR
Entry in to Force 25 May 2017
NBs designationunder IVDR
Date of Application26 May 2022
IVDD certificatevalidity (2 years )
IVDD certificates can be issued/re-issued/renewed
IVDR certificates
Transition period5 years
No more « makingavailable or putting
into service » of devices covered by IVDD certificates
IVDD certificates void27 May 2024
27 May 2025
NBs can apply for designation26 Nov 2017
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Notified Bodies Transition (Designation) Process
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NB Designation Process
Source NBM-046-187
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Tightening of NB oversight began a few years before MDR
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• 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
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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
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Status of NB Applications under MDR / IVDR - May 2021
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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
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Status of NB Applications under MDR / IVDR - May 2021
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5
10
15
20
25
30
Directives Regulation
NB Requirements (Chapter IV, Annex VII)
Number of Pages
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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
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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
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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
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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
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Implementing Act - Codes (EU) 2017/2185
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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
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Designated Notified Bodies (16 September 2021)
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MDR = 24
IVDR = 6
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MDR Transition Timeline
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
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
We are here
Countdown
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Directive Certificates
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Reconciliation of time left to certificates expiring
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Questions?