Europe – Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals

A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence route for approvals to include jurisdictions such as the US.

Last year, members of the UK Life Sciences Council, which brings together government, regulators and industry, formed an advisory group to create recommendations on the reform of medtech regulation. With the UK leaving the European Union, the Council saw a “golden opportunity” and tasked the group with providing advice about international recognition, routes for innovation and system capacity.

Months later, the group has delivered 10 recommendations, including three that are designed to “ensure the supply of safe medical devices to UK patients is maintained through expanded recognition (e.g. to US approvals) and removing burden where possible.”

Building on current product recognition routes from the EU, the recommendations advise officials to “rapidly explore building a UK product regulation equivalence route for the approvals of medical devices to include other trusted jurisdictions such as the US for a greater proportion of products.”…