Feb 28, 2021
The cornerstone of the UK’s post-Brexit medical device regulatory system, the Medicines and Medical Devices Act 2021, received royal assent and passed into law on February 11, having been introduced in the House of Commons almost a year previously. The bill mirrored the focus on patient safety found in the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), providing mechanisms for punishing regulatory violations and releasing information about products that pose a threat to public safety.
While the original composition of the bill passed by the House of Commons appeared to be focused on providing a UK equivalent to the MDR, a concurrent investigation into several public health scandals had a major impact on its development. In July 2020, the Independent Medicines and Medical Devices Safety Review (IMMDS Review) published its report on the harm caused by hormone pregnancy tests (HPTs), sodium valproate, and pelvic mesh implants, with recommendations for how to avoid such problems in the future. Among the recommendations found in this report were 1) the appointment of a patient safety commissioner to coordinate government actions when medicines and medical devices fail, and 2) the creation of a patient-identifiable national database of all implantable medical devices currently in use.
Starting in the House of Lords, the bill was extensively amended to incorporate the recommendations of the IMMDS Review Report. The final version of the bill also included a greater emphasis on the overriding importance of patient safety as the heart of the UK regulatory system, adjusting the original language that put safety on a seemingly equal footing with the attractiveness of the UK market to foreign companies.
A full statement detailing the initial government response to the publication of the IMMDS Review Report can be found here. Readers may peruse the language of the Medicines and Medical Devices Act 2021 in its entirety here.
The British regulatory agency added a section to its general guidance on medical device and IVD registration, providing information on grace periods, representative appointments, and required declarations.
New Coordinated Assessment Pathway to expedite medical device clinical trial reviews in the UK
UK MHRA registration requirements and compliance grace periods for medical devices and IVDs
Post-Brexit challenges for placing medical devices on the market in Northern Ireland