UK Healthcare Regulations New Statement of Policy Intent to further recognize U.S. medical devices

In May 2024, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published the much-anticipated Statement of Policy Intent outlining how the agency will recognize regulatory approvals from certain markets, including the United States depending on the device type, class, and prior approval. The purpose of this new policy is to ensure British patients continue to have safe access to quality-assured medical devices while at the same time reducing the duplication of assessments by comparable regulators – thus helping innovative technology enter the British market faster. Though still in draft form and not yet official policy, this statement of policy intent signals to medical device manufacturers to start considering whether their devices will be eligible for the proposed alternative routes to market.

Companies selling their medical devices internationally and which already have authorizations in the United States, Australia, Canada, or the European Union may be eligible to fast-track their medical devices into the UK market. For companies in the United States, in many cases regulatory approval from the U.S. Food and Drug Administration will be recognized by the UK’s MHRA for fast-track approval. However, there are different requirements for different types of authorization and categories of device. Nevertheless, for many devices there will be no formal authorization process, but rather a filing of paperwork with MHRA.

Dr Laura Squire, Chief Quality and Access Officer of the MHRA said “Today’s announcement is an important step forward towards a robust MedTech regulatory framework that prioritizes patient safety, gives patients access to the medical devices they need and ensures the UK remains an attractive market for medical technology innovators. We will continue to work on how our intended policy on international recognition of medical devices will operate in practice. By sharing the draft policy now, we aim to give greater clarity about the MHRA’s future direction of making regulatory approvals simpler, where it is safe to do so.”

This statement of policy intent presents increased export potential for U.S. companies with expertise in medical devices. U.S. companies have a worldwide reputation for innovative products, after sales service, and training which makes them competitive in the UK market. The U.S. and UK also share similar business cultures and business practices, which makes the UK an attractive market for U.S. suppliers.

Please view the UK Government’s official announcement in full.

For more information, please contact Stephen Brown at the U.S. Embassy London via Stephen.Brown@trade.gov.