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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