On 26 June 2022, the MHRA published the UK Government’s response to the consultation on the regulatory framework for medical devices in the UK (the Response), and following analysis of the nearly 900 responses received, its intentions for the future UK regulatory regime for medical devices (the UK Regulations).
In September 2021, we posted about the MHRA’s consultation, with a summary of the proposals set out across 15 technical chapters. The consultation ran between September and November 2021, and focused on patient safety and innovation, whilst recognising that gaining and maintaining competitiveness in a global market will be best supported by aligning with internationally recognised best practice and standards.
We have considered the Response and set out some of the key factors we consider to be of particular interest below. We have not precisely follow the order in the Response and have not covered every aspect or changes; this is necessarily a high level summary.
While the approach the MHRA intends to take in the UK Regulations is clarified and set out in more detail in the Response, no draft statutory text has yet been published. A lot of detail will also be left to guidance that will accompany the UK Regulations. It will therefore be important to see how closely aligned the new UK framework is to the proposals described in the Response and with international rules and standards.