Module 17 2024

05/12/2024

Transition Period

MDR/IVDR will not be fully used in the future under the UKCA process. The UKCA process is currently based on the requirements of MDD 93/42/EEC, IVDD 98/79/EC, and AIMD 90/385/EEC.

Manufacturers outside of the UK are required to register a UK Responsible Person

GB manufacturers supplying into the EU have required an EU Authorised Representative since 1 st January 2021

Note: GB is defined as England, Scotland, & Wales, whereas the UK relates to England, Scotland, Wales, & Northern Ireland.

The Organisation for Professionals in Regulatory Affairs

7

7

Transition Period

The Organisation for Professionals in Regulatory Affairs

8

8

4