UK's MHRA and FDA Move to Align Device Rules and Explore Mutual Recognition

The UK's medicines and devices regulator has committed to working with the US Food and Drug Administration to improve and align medical device regulation, with mutual recognition of parts of each other's approval processes among the options on the table, MedTech Dive reported on April 7.

In its statement, the Medicines and Healthcare products Regulatory Agency (MHRA) said it and the FDA "will work closely on options to improve and align regulations for medical devices." That includes exploring future mutual recognition mechanisms, which the agency described as ways to recognise parts of the individual approval processes, along with reducing duplication for manufacturers and streamlining approvals.

The MHRA said technical work between the two regulators will continue over the coming months to assess opportunities for closer alignment. It said both regulators' work will remain independent and that any future arrangements will continue to meet the UK's statutory requirements for safety, quality and effectiveness.

Built on the pharmaceutical deal

The device announcement was framed as building on the wider US-UK pharmaceutical partnership, which the UK government said removes tariffs on UK medicines exports. The MHRA statement did not set out a timetable or name specific device categories.

"This marks an exciting moment for UK innovation," said Lawrence Tallon, the MHRA's chief executive. "Importantly, this is just the beginning, and I am looking forward to building on the growing US-UK collaboration as we continue to strengthen our shared commitment to safe, high-quality innovation for patients."

UK industry groups welcomed the move. Peter Ellingworth, chief executive of the Association of British HealthTech Industries, called closer cooperation "a positive step towards reducing regulatory duplication and accelerating patient access to HealthTech that saves and enhances lives." Julian David, chief executive of techUK, said the commitment is "an important step forward for patients and for the UK's health sector."

Reliance routes and EU recognition

Mutual recognition has been a recurring UK goal since Brexit. MedTech Dive noted that the MHRA proposed recognizing US device approvals in 2024, and that the UK government last year committed to three international reliance routes that use authorizations issued in Australia, Canada, the EU and the US. Under those routes, the approved bodies that assess medical technologies in the UK would carry out truncated reviews tailored to each product's risk class, the publication reported.

The MHRA is also running a consultation, which MedTech Dive said closes this week, on whether to indefinitely recognize devices that comply with EU medtech regulations. The proposal responds to a recurring request from an earlier consultation on UK device regulation, according to the report.

The MHRA, an executive agency of the Department of Health and Social Care, is based at 10 South Colonnade in London's Canary Wharf. The two regulators have worked together before: MedTech Dive noted that in 2021 the MHRA published guiding principles for good machine learning practice with the FDA and Health Canada.