Medical Devices Regulations Updates Including Stand Still Period Extension
On 21 October 2022 we received notification from the MHRA of their intention to extend the standstill for the implementation of the UK MDR.
Initially it was intended that the regulation would be implemented from the 1 July 2023 but as the new Medical Device regime is a substantial reform of the current framework, an extension of 12 months was proposed.
Once the extension has been passed by parliament, the UK MDR will be implemented on 1 July 2024.The transitional arrangements for the move to the UK CA for medical devices is proposed to be up to five years from that date, dependant on the type of classification.
Shortly after the MHRA notification, the Department for Business, Energy and Industrial Strategy (BEIS) announced its intention to extend the transition period for UK CA Marking of non-medical devices by two years, so the date of commencement for most products will be 1 January 2025.
The regulatory world is subject to change, especially with the proposal put forward by the EU to extend the transition period for medical devices and in vitro diagnostic medical devices for EU MDR as well.
Until it is legislated it is difficult to determine the impact on the UK, so multi-disciplined team across NHS Supply Chain and external parties are working together such as MHRA, DHSC to understand the implications of the changes.
We are again asking all our suppliers to inform us of the impacts on them as a result of the proposed extensions, and also any decisions they have taken about the availability of products to the UK market as a result of the recent announcements both in the UK and EU.
If you have further questions about any of the above, please contact us.
Regulatory Change Team
See our Useful Links section for more details, including::
- Consultation on the future regulation of medical devices in the United Kingdom.
- Medicines and Healthcare products Regulatory Agency on Gov.uk website.
- Medical devices – transition period extension.
- Businesses to be given UK product marking flexibility
- Regulations Updates – MDR – UK CA (2019 – 2023).