The Medical Devices Introductory Course 2020

• New IVD Regulation 2017/746 will apply from May 26 th 2022. • Much greater control over all economic operators, plus development, performance and post market monitoring. • Introduces the new role of PRRC • NB approval for ¾ risk classes plus new class of near patient tests • New database with more publicly available information History of IVD Regulation - EU

The Organisation for Professionals in Regulatory Affairs

IVDR Content & Structure + Preamble

10 Chapters & 113 Articles

15 Annexes

I

1-4

Scope and definitions

I

General safety and performance requirements

II

Technical documentation

II

5-21

Making available and putting into service of devices, obligations of economic operators, re- processing, CE marking, free movement Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European databank on medical devices

III

Technical documentaion on post-market surveillance

IV EU declaration of conformity V CE marking of conformity VI

III 22-30

Information to be submitted, registration (UDI)

VII

Minimum requirements, notified bodies (NB)

IV 31-46

Notified Bodies

VIII Classification rules IX Conformity assessment based on a QMS and on assessment of technical documentation X Conformity assessment based on type examination XI Conformity assessment based on production quality assurance XII Certificates issued by a notified body XIII Performance evaluation, performance studies and post-market follow-up XIV Interventional clinical performance studies and certain other performance studies XV Correlation table

V 47-55

Classification and conformity assessment

VI 56-77

Clinical evidence, performance evaluation and performance studies

VII 78-95

Post-market surveillance, vigilance and market surveillance

VII I 96-101 Cooperation between Member States, Medical Device Coordination Group, EU reference laboratories, device registers IX 102-106 Confidentiality, data protection, funding, penalties

The Organisation for Professionals in Regulatory Affairs

X 107-113 Final provisions