Module 17 2024

05/12/2024

Northern Ireland

This issue is obviously a highly politicised area, which also includes the ongoing Peace Process in Northern Ireland through the Good Friday Agreements [one of whose points is that there cannot be an internal border between Northern Ireland and the Republic of Ireland]. The Northern Ireland protocol contained in the Brexit agreement is still a source of discussion between the UK and the EU, with the main focus on the UK trying to modify the protocol. Currently, Northern Ireland is de facto still a full member of the EU, requiring compliance with all EU laws and regulations. It is, therefore, likely that changes to the Northern Ireland protocol will occur in the near future.

The Organisation for Professionals in Regulatory Affairs

11

11

MHRA Consultation Process on UKCA

Between September – November 2021, the MHRA consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). The MHRA issues a consultation document containing 15 Technical Chapters for comment. The MHRA received 891 consultation responses: 413 from individuals and 451 from organizations . The MHRA published their response and final conclusions on the consultation process on the 26 th June 2022.

The Organisation for Professionals in Regulatory Affairs

12

12

6