Background

The Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible changes to how medical devices will be regulated in the UK in the future. The changes are likely to be implemented through amendments to the existing Medical Devices Regulation 2002.

This consultation is particularly pertinent in light of the recent introduction of new EU regulations governing medical devices and in-vitro diagnostic devices. Given that these regulations were implemented post-Brexit, they will not be implemented in the UK. For further information on these developments, you can view our recent article which explores this in more detail

The MHRA is an executive agency of the Department for Health and Social Care within the UK government, which is responsible for regulating and ensuring the safety of medicines and medical devices in the UK. The MHRA’s aim is to develop a regime for medical devices which enables the following:

• Improved patient and public safety;
• Greater transparency of regulatory decision making and medical device information;
• Close alignment with international best practice, and;
• More flexible, responsive and proportionate regulation of medical devices.

The consultation

The consultation focuses on 17 key areas and respondents can select which of these areas they are interested in responding to: (1) Scope of the Medical Devices Regulations 2002; (2) Classification of medical devices; (3) Economic Operators; (4) Registration and UDI; (5) Approved Bodies; (6) Conformity Assessment; (7) Clinical Investigations/ Performance Studies; (8) Post-market Surveillance and Vigilance; (9) In Vitro Diagnostic Medical Devices; (10) Software as  Medical Device; (11) Implantable Devices; (12) Other Product-Specific Changes; (13) Environmental sustainability and public health impacts; (14) Routes to Market; (15) Transitional Arrangements; (16) Feedback; and (17) Questions for members of the general public.

Each key area is then divided into sub-areas of focus, so that respondents may further limit the scope of their responses to areas in which they have a particular interest or knowledge. For each section, a summary of the background to the area in question as well as a list of the possible changes relevant to each area are provided. Respondents are then asked a series of questions related to the particular area and are afforded the chance to add additional comments in the spaces provided.

The consultation is open to anyone wishing to share their views, but the views of those who are (a) healthcare professionals; (b) regular users of medical devices; and/ or (c) carers or support providers for a regular user of medical devices are of particular interest to the MHRA.

The consultation will close at 11:45 on 25 November 2021. Click the link here for further information and instructions on how to respond.