Consultation outcome

Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

From:
Medicines and Healthcare products Regulatory Agency
Published
14 November 2024
Last updated
26 February 2025 — See all updates
This consultation has concluded

Read the full outcome

Response to Assimilated EU Law consultation proposal

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Response to Assimilated EU Law consultation proposal

PDF, 290 KB, 12 pages

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Detail of outcome

This document sets out the government response to the proposal regarding assimilated EU law only. The response to proposals regarding international reliance, UKCA marking and in vitro diagnostic devices will be published separately in due course.

Original consultation

Summary

The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.

This consultation ran from
to

Consultation description

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals to update the regulatory framework for medical devices. 

We welcome the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public on four areas: 

  • International reliance 
  • UKCA marking 
  • In vitro diagnostic devices 
  • Assimilated EU law

This consultation applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

Documents

Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

PDF, 589 KB, 44 pages

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Consultation survey questions

PDF, 281 KB, 13 pages

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Updates to this page

Published 14 November 2024
Last updated 26 February 2025 + show all updates

  1. Published government response to the proposal regarding assimilated EU law only. The response to proposals regarding international reliance, UKCA marking and in vitro diagnostic devices will be published separately in due course.

  2. First published.

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