MHRA - Medicines and Healthcare products Regulatory Agency

11/14/2024 | Press release | Distributed by Public on 11/13/2024 18:14

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

Open consultation

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

From: Medicines and Healthcare products Regulatory Agency Published 14 November 2024
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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 closes at
11:59pm on 5 January 2025

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.

The preferred method of responding is through the link above. However, if you wish to submit a written response to the consultation, please send to:

Medical Devices Consultation
MHRA
10 South Colonnade
Canary Wharf
London
E14 4PU

Postal responses must be received before 5 January 2025.

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

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email [email protected]. Please tell us what format you need. It will help us if you say what assistive technology you use.

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Updates to this page

Published 14 November 2024

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