Prime Highlights:
- The Medicines and Healthcare products Regulatory Agency (MHRA) plans to continue recognising EU-approved medical devices to ensure steady access for patients.
- The move aims to support both patient safety and the medical technology sector by reducing supply disruptions and regulatory burden.
Key Facts:
- Around 90% of medical devices used in Great Britain are CE-marked, showing strong reliance on EU-approved products.
- The proposal includes extending current rules, continuing EU compliance recognition, and introducing a new pathway for higher-risk devices.
Background:
The Medicines and Healthcare products Regulatory Agency (MHRA) has started a consultation to keep recognising EU-approved medical devices for the long term, to protect patient access and ensure a steady supply in Great Britain.
It also plans to extend the 2023 rules that allow CE-marked devices to be used in the UK market. Under the new proposal, these measures could run until 2030 and potentially continue beyond that timeframe.
According to the agency, nearly 90 percent of medical devices used in Great Britain carry CE certification. Extending recognition would help avoid supply disruptions and ensure patients continue to receive safe and effective treatments.
The Medicines and Healthcare products Regulatory Agency is asking for feedback on three proposals. These include extending current arrangements for older EU-approved devices, continuing recognition of devices under updated EU rules, and introducing a new pathway for higher-risk CE-marked devices.
Stakeholders have been invited to share their views online, either supporting or raising concerns about the proposed measures.
MHRA Chief Executive Lawrence Tallon said the proposals respond to industry demand for long-term clarity on CE recognition. He noted that maintaining access to European-approved devices serves both patients and the medical technology sector by reducing costs and regulatory barriers.
He also indicated that the UK will position its own approval system as a specialised route for innovative products, including artificial intelligence-based medical devices. This approach will align with recommendations expected from a national review on AI regulation in healthcare.
Alongside the consultation, the Medicines and Healthcare products Regulatory Agency has expanded its work and introduced paid advisory meetings for manufacturers.
Overall, this shows the MHRA’s effort to ensure patient safety, support innovation, and maintain market stability while aligning with European standards.
