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