Module 16 2024

24/10/2024

Disclaimer

This presentation is based on current understanding of the UK & EU Medical Devices Regulations and guidance.

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

2024-10-24

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Agenda

What are the UK Medical Device Regulatory Requirements for medical devices

01

Overview of draft PMS SI and new UK PMS requirements

02

03

Role of the AB / NB in PMS & Vigilance

04

PMS & Vigilance Guidance

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

2024-10-24

4

4

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