MedTech Dive May 24, 2024
Nick Paul Taylor

Companies with authorization in certain regions, including the EU and U.S., would be able to use their approvals to access Great Britain’s market.

Dive Brief:

  • The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) said Tuesday it plans to recognize medical device approvals from comparable regulators.
  • Under the proposed policy, companies that have received authorization in regions including the European Union and U.S. will be able to use their approvals to access the Great Britain market.
  • MHRA is proposing the framework and plans to finalize it alongside broader changes to medical device regulations in Great Britain, which are due to take effect next year.

Dive Insight:

Brexit required MHRA to rethink medical device pathways. Before Brexit, companies...

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