Consultation on the future regulation of medical devices in the United Kingdom

Overview

Between September and November 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK).

The aim was to seek views on developing a future legislation for medical devices which delivers:

• 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 sought the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public to help shape our future approach to regulating medical devices in the UK. It contained 15 technical chapters, one chapter on general feedback (Chapter 16) and one chapter on a range of topics aimed at lay persons and those with limited time (Chapter 17 – which we refer to in this document as the ‘abridged consultation’ chapter). The government response covers Chapter 17 of the consultation, and responses to it, within the main chapters where relevant (rather than having a dedicated chapter on responses to Chapter 17 as a whole).

This content is available under the Open Government Licence v3.0

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