As covered previously, the UK Parliament is in the process of advancing the Medicines and Medical Devices Bill, which would form the foundation of a post-Brexit framework for medical device regulation. The bill was passed at the Second Reading before the House of Commons on March 2 and will next be reviewed by a Public Bill Committee. The membership of the committee and date of the review have yet to be announced, but a report to the House is expected by April 23.
New factsheet explores implications for medical devices
While the bill progresses, the Department of Health and Social Care (DHSC) has released a series of publications related to the legislation, including ten factsheets on various subjects. One of these factsheets deals specifically with medical devices.
The factsheet provides an explanation of medical device classification in the UK and a flowchart illustrating the regulatory cycle. It also implies a high level of continuity with the EU’s Medical Devices Regulation (MDR), with language emphasizing that the MDR will go into effect in May and stressing that this bill would allow the government to maintain its robust levels of regulation. Three device categories singled out for what appears to be stricter regulation than that mandated by the MDR are the same ones previously cited by the government: pacemakers, breast implants, and ultrasound imagers.
We will continue to provide updates on the Medicines and Medical Devices Bill as new developments take place.
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