Feb 19, 2020

For everyone wondering about the short-term future of medical device regulation in the post-Brexit UK, there is now a preliminary indication as to how the government may go about setting up its own framework. The Medicines and Medical Devices Bill, which was initially announced in the Queen’s Speech on December 19, 2019, was presented to the House of Commons for its First Reading on February 13. The Second Reading is tentatively scheduled for March 2.

Charting a new course for UK medical device regulation

The Bill introduces new regulations on certain medical devices, including pacemakers, breast implants, and ultrasound imagers, with an emphasis on ensuring the safety of patients. It also provides for the Medicines and Healthcare products Regulatory Agency (MHRA) to fast-track regulatory processes for novel technologies (such as treatments utilizing artificial intelligence) and to more strictly enforce consequences for breaching medical device regulations. Finally, the Bill delegates to the Health and Social Care Secretary the power, within certain guidelines, to disclose information about medical devices to the public when serious concerns over patient safety arise.

Medical devices constitute Part 3 of the Bill, with chapters on regulations, enforcement, and disclosure of information. The Bill also allows hospitals to develop individualized treatments for patients with unique conditions, and it widens the range of professions eligible to prescribe medicines in low-risk situations. The UK Government’s website published a news article with a summary of the Bill’s major provisions.

A legislative work in progress

Further analysis can be found in the Explanatory Notes prepared by the Department of Health and Social Care (DHSC). The progress of the Bill can be monitored on the UK Parliament’s website.​ While it is entirely possible that the final law will deviate significantly from this initial piece of draft legislation, it does provide a window into the preliminary conversations on medical device regulation taking place in the House of Commons.

Related UK medical device regulatory resources from Emergo by UL:

  • Brexit transition consulting for medical device and IVD companies
  • Whitepaper: How medical device companies can prepare for a no-deal Brexit
  • Whitepaper: How to select or change your Notified Body
  • Webinar: Impact of a no-deal Brexit

Author

  • Timothy Herr

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