Module 16 2024

24/10/2024

CE transition timelines

UK introduced legislation defining CE transition periods: The Medical Devices (Amendment) (Great Britain) Regulations 2023 (legislation.gov.uk)

MHRA published infographic describing transition periods (below): MHRA Infographic: transition periods under new UK SI

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

2024-10-24

9

9

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

10

10

5