Module 16 2024

24/10/2024

UK, Great Britain, Northern Ireland

• United Kingdom • Great Britain (GB) • Northern Ireland (NI)

• Great Britain • England • Scotland • Wales

• Northern Ireland Protocol • Different rules in NI

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

5

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What are the current legislative requirements for medical devices in UK?

The Medical Devices Regulations 2002 (SI 2002 No 618, as amended)(UK MDR 2002)

The Medical Devices (Amendment) (Great Britain) Regulations 2023

Laid in Parliament Oct 2024

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 [DRAFT] Pre-market SI, Innovative Devices Access Pathway (IDAP), International Recognition / Reliance (IR), AI Airlock…..

The role and responsibilities of ABs & NBs in PMS & V

2024-10-24

6

6

3