A roadmap outlining the intended timelines for delivering a
future regulatory framework for medical devices and an intended
policy on international recognition.
Published 25 October 2022
Last updated 11 December 2024 — See all updates
Implementation of the future
regulations
Details
Overview
On 26 June 2022, the MHRA published the government response to the
public consultation on the future regulation of medical devices
in the United Kingdom. The response outlined the intended
regulatory reform including the transitional arrangements for CE
marked devices placed on the Great Britain market which were put
in place in 2023.
On 9 January 2024, the MHRA released a Roadmap towards the future
regulatory framework for medical devices. This provided an update
on the intended timelines to implement the future core
regulations.
On 21 May 2024, following on from stakeholder discussions
throughout the first quarter of 2024, the MHRA released a
statement
of policy intent for recognition by the UK of approvals of
medical devices from international regulators. This statement
sets out MHRA's proposed policy approach. The final legal text
would come into force at the same time as the future core
regulations.
On 14 November 2024, the MHRA published the Consultation on Medical
Devices Regulations: Routes to market and in vitro diagnostic
devices. The results of this consultation will inform
legislative updates to the regulatory framework.
On 11 December 2024, the MHRA published a revised Roadmap
towards the future regulatory framework for medical devices.
This provides a further update on the intended timelines to
implement the future medical device regulations.
