MedTech Dive May 24, 2024
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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