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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.

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Matthew Ruth

Matthew Ruth’s practice focuses on global patent prosecution and intellectual property portfolio management. He is also experienced with issues involving U.S. regulatory governance and antitrust.

Matthew assists clients in a range of technical fields including artificial intelligence, clean energy, electrical engineering, and electromechanical devices.

Matthew received his J.D. from the Sandra Day O’Connor College of Law at Arizona State University, where he worked with the Center for Law, Science, and Innovation on matters relating to the governance of emerging environmental technologies and artificial intelligence. Matthew also served as Senior Executive Editor of Jurimetrics, The Journal of Law, Science and Technology. During law school, Matthew worked with small business clients handling employment and IP contracting through the Innovation Advancement Clinic. He also worked as an advocate for small businesses in Washington D.C. on matters relating to antitrust, data privacy, and patents in the year prior to graduation. Upon graduation, Matthew received the Strouse Prize recognizing his contributions to the Law, Science, and Technology program at Arizona State.

Before attending law school, Matthew worked as an independent consultant specializing in geographic data analysis and interned as a telecommunications engineer.

Matthew joined the firm in 2022.

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