UK Proposes Approving Medical Devices Based on Approval in Other Countries

Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom.  On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of intent for what could be a significant shift in policy: approval to market and sell medical devices based on prior approval from a comparable regulatory country (CRC). Medical devices approved under the new framework would be allowed into the UK market but would not receive the UK Conformity Assessed (UKCA) certification. Market availability would be determined based on the CRC approval.

The MHRA lists CRCs, which include the U.S., Australia, Canada, and countries in the European Union (e.g., United States Food and Drug Administration, Australian Therapeutic Goods Administration, Health Canada).  To be eligible, a product must comply with relevant laws in the CRC, have English labelling and packaging, comply with various requirements for electronics compatibility and units of measurement, have a UK responsible person, have a physical unique device identifier, and comply with new post-market surveillance requirements expected to come into force in 2024. Approvals must conform to the CRC-authorized device on which the application is based. This includes not only the final manufactured device, but also the manufacturing process and intended purpose of the device. Certain classes of medical device would be exempted from international recognition, a list of which can be found here. Notably, the proposed framework excludes devices approved under the U.S. Food and Drug Administration’s Section 510(k) clearance.

According to Dr. Laura Squire of the MHRA, the proposed framework will give “patients access to the medical devices they need and ensure[] the UK remains an attractive market for medical technology innovators.” When the proposed framework is approved, medical device manufacturers may be able to expedite and simplify medical device approvals for the UK market.