UK passes post-Brexit medical device regulatory bill into law

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.

Bill to regulate medical devices was impacted by report on public health failures

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.

Further reading on impact of new legislation

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.

Related UK and European Union medical device and IVD regulatory resources:

• UKRP and Brexit transition consulting for medical device and IVD companies
• EU Medical Devices Regulation (MDR) preparation and compliance resource center
• European MDR, IVDR and ISO 14155 clinical compliance consulting
• Post-market clinical follow-up (PMCF) studies for medical devices
• Whitepaper: Placing medical devices and IVDs on the post-Brexit UK market

Related services for Europe:

• CE Mark Certification for Medical Devices
• Clinical Evaluation Reports (CER) for Medical Devices in Europe
• EU IVDR Gap Assessment and CE Transition for IVD Companies
• EU MDR compliance consulting for cosmetic and aesthetic products
• EU Medical Device Vigilance Reporting in Europe
• EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
• European Authorized Representative for Clinical Trials
• European Authorized Representative for Medical Device Companies
• European MDR 2017/745 Gap Assessment and CE Transition Strategy
• European Union Medical Device Classification
• In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
• IVD Certification and Registration to Obtain CE Marking in Europe
• Medical Device and IVD Emergency Use Routes in Europe
• Medical Device Technical File and Design Dossier for EU CE Marking
• Switzerland Representative for Medical Device Companies
• UKRP and Brexit consulting for medical device companies