MEDICAL DEVICE REGULATION (MDR)
MEDICAL DEVICE REGULATION (MDR)
EUROPE
Volker Zeinar 07 Nov 2019 - GS1 Healthcare Conference, New Delhi
AGENDA
I. MDR overview II. UDI requirements III. EUDAMED IV. Conclusion
EU Regulation MDR 2017 / 745
KEY DATES MDR Publication 05 May 2017 Entry into force 26 May 2017 Date of Appl. 26 May 2020 Transition Period 26 May 2024
Chapte r
Subject
I
Scope / Definitions
II
Making available +putting into service, obligations economic operators, reprocessing, CE marking, ...
III
Identification, traceability, registration of economic operators + devices, EUDAMED, ...
IV
Notified Bodies
10 chapters - 123 articles - 17 annexes 175 pages - replaces the MDD 93/42/EC
V
Classification / conformity assessment
Anx
VI
Clinical evaluation / investigation
I
VII
Post-market surveillance, vigilance, market surveillance
II
VIII
Cooperation between MS, Med Dev Coord. Group, expert panels, ... ...
IX
Confidentiality, data protection, funding, penalties
VI
X
Final provisions
...
XVII
B. Braun Melsungen AG
Subject General safety + performance requirements Technical documentation ... Registration + UDI ... ...
S C O P E all Medical Devices
Except : Custom-made dev Perform.study/investig. dev
3
MDR Building Blocks
Classification
Technical Documentation
Scrutiny
Clinical Evidence
Vigilance
Market Surveillance
Person responsible for
Regulatory Compliance
NNoottiiffied BBooddiieess
UDI EEUuDdAamMeEdD
B. Braun Melsungen AG
4
MDR Building Block 1
Classification
Technical Documentation
Scrutiny
UDI
Person
What does it mean? Vigilance
responsible for
? ReceRretgifuiclaatotiroyn of all approved devices
Compliance
Clinical Evidence
? Reclassification / new classification rules
Market ? Stricter pre-market control (high risk dev)
Surveillance
NNoottiiffied BBooddiieess
EEUuDdAamMeEdD
? Structure of RMF changes / more content
B. Braun Melsungen AG
5
MDR Building Block 2
Classification
Clinical Evidence
Technical Documentation
Vigilance
Market Surveillance
? New rules/more clinical investigat.
? SMcrourtienyrigorous clinical evidence
? Publ. of safety + performance data
UDI
? NPeBrs'sonincreased authority (PMS) re?sRpeUognnuslaaibtnolenryfoour nced audits (MD sample checks) ?CoSmtprleianngcethening PMS requirem. MFR
? Periodic Safety Reports (4 types)
NNoottiiffied BBooddiieess
EUDAMED
B. Braun Melsungen AG
6
MDR Building Block 3
Person responsible for :
? product conCfloasrsmifiictyaticohn eckeDdocTbueecmfhoennricteaatlion batch release
? Tech. doc up-to date
Vigilance
? Vigilance reports, FSCA, ...
NB :
Clinical Evidence
? re-accreditation
Market Surveillance
? Strengthened designation criteria
? Number will be reduced
Scrutiny
Person responsible for
Regulatory Compliance
NNoottiiffied BBooddiieess
UDI EEUuDdAamMeEdD
B. Braun Melsungen AG
7
MDR Building Block 4
Classification
Technical Documentation
Scrutiny
Clinical Evidence
Vigilance
Market Surveillance
Person responsible for
Regulatory Compliance
NNoottiiffied BBooddiieess
UDI EEUuDdAamMeEdD
B. Braun Melsungen AG
8
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