Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
Read the full outcome
Detail of outcome
This document sets out聽the government response to the proposal regarding assimilated EU law聽only. The response to proposals regarding international reliance, UKCA marking and in vitro diagnostic devices will be published separately in due course.
Original consultation
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.聽
We welcome the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public on four areas:聽
- International reliance聽
- UKCA marking聽
- In vitro diagnostic devices聽
- Assimilated EU law
This consultation applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see聽Regulation of devices in Northern Ireland.
Documents
Updates to this page
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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.
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First published.