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Medicines and Healthcare products Regulatory Agency gov.uk

Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices

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The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain.

We welcome the views from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organisations. 

We are inviting views on the following proposals:

  • Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Devices Regulation 
  • Indefinitely recognising devices that comply with the EU Medical Device Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR), and 
  • Introduction of an international reliance route for devices classified higher in Great Britan than in the EU. 

    • This is an extract. The publication continues at the source.

    Contains public sector information licensed under the Open Government Licence v3.0. Licence

    Read the original at the source: https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devices

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    Medicines and Healthcare products Regulatory Agency — imported from official source
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    https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency.atom ATOM
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    October 21, 2026 09:01
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    https://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consul...

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