UK – Brexit and the UK’s medical device usability requirements

It is expected the UK and the EU will not agree to retain the regulation of medical devices within a common EU regulatory framework. This means that from January 1st 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will become the standalone medicines and medical devices regulator for the UK.

CAB, UKCA and other post-Brexit changes

With regards to the regulation of medical devices, the UK Government is planning a new piece of legislation called the Medicines and Medical Devices Bill. The MHRA has already stated in its most recent advice that it intends to “take into consideration international standards and global harmonisation” in the development of any future system of medical device regulation. And that they will “identify and prioritise elements of international practice that promote public health and patient safety.” So two themes emerge: (1) the role of international standards, and (2) the desire to align with global requirements where possible…