Today the MHRA made three significant announcements:
- They will accept CE Marked devices in Great Britain until 30 June 2030, depending on the type of device.
- They are aiming for the future UK medical device regulation to apply from 1 July 2025. This is separate from the post-market surveillance (PMS) requirements, which will come into force earlier than the new regulation – PMS is currently expected to apply from mid-2024.
- It appears after the new legislation is in force (1 July 2025), it will not be possible to rely on EU MDR/IVDR CE Certificates which are renewed after that date. More information from the MHRA is needed to better understand this announcement.
The announcement is: HERE
The three topics are covered in more detail below.
Longer Acceptance of CE Marking
The new timeframes in which CE Marked devices may be marketed in Great Britain are:
- MDD/AIMDD CE Marked legacy devices – until 30 June 2028 or the CE Certificate expires
- IVDD CE Marked legacy devices – until 30 June 2030 or the CE Certificate expires
- MDR/IVDR CE Marked devices – until 30 June 2030 or the CE Certificate expires
The MHRA states that expired certificates are not accepted in Great Britain unless they have been deemed valid under the EU’s extension to the MDR transition period.
For more information on the EU’s legacy device extension period under Regulation 2023/607, please read: MDR Transition Extension Guide
- It is unclear how the above aligns to the MHRA’s statement that renewed MDR/IVDR CE Certificates cannot be used to continue marketing; more information is needed from the MHRA on this point.
- The MDD/AIMDD/IVDD products must be legacy devices as defined in the EU.
- E.g., an MDD Class I self-certified device must have been lawfully CE Marked on 26 May 2021 and the device must have been up-classed under the MDR.
- The MDR transition period allows MDD/AIMDD Class III custom-made implantable devices to be placed on the EU market until 26 May 2026, if the manufacturer meets certain conditions. However, the MHRA has stated MDD/AIMDD-compliant custom-made devices may not be placed on the market in Great Britain.
- The above does not exempt companies from 1) appointing a UK Responsible Person (if outside of the UK) and 2) registering their devices with the MHRA (all manufacturers, both in and out of the UK).
- For more information about the requirements, please read: UK Steps to Market
- This announcement is applicable to Great Britain (England, Scotland, Wales). Northern Ireland, the fourth UK country, requires EU CE Marking and does not recognize UKCA Marking.
How to register with an expired CE Certificate still technically valid under the MDR extension:
The MHRA has updated its Medical Device Registration guidance to add sections regarding how to register “certain medical devices that have expired/expiring CE certificates” and “certain medical devices which are EU MDD Class I reusable surgical instruments or EU MDD Class I medical devices upclassified from Class I”.
If the CE Marking certificate has expired, but is still valid per EU Regulation 2023/607, then a template letter created by the MHRA must be provided in the registration application. The template letter is available in the above Medical Device Registration guidance link.
The letter must be signed by the Manufacturer and, where applicable, the UK Responsible Person/Northern Ireland Authorized Representative.
What about expiring/expired MDD/AIMDD CE Certificates for devices already registered in the UK?
If the certificate is eligible for the extended MDR transition period, then the MHRA encourages companies to update their MHRA registration.
If you are a UK-based manufacturer, then you can follow the steps outlined: HERE
If you are a non-UK-based manufacturer, then you should contact your UK Responsible Person for support in completing the template letter and updating your registration record.
There is currently no fee to make this change.
New Date for Future UK Medical Device Regulation
Today’s announcement states:
“This guidance has been updated to reflect that the government is now aiming for core aspects of the future regime for medical devices to apply from 1 July 2025.”
The MHRA also confirms the new 2025 date in this separate announcement:
“We are aiming for the revised framework to now apply from July 2025. In setting this timeline we have taken on board feedback from external stakeholders, such as concerns about limited capacity of conformity assessment bodies.”
Acceptance of Renewed MDR/IVDR CE Certificates After New UK Regulation
Today’s announcement states:
“The government also intends to make a further amendment in future. This will provide that, once the future regime for medical devices is in place, it will not be possible to rely on EU MDR or EU IVDR CE certificates that are renewed after the future regime fully applies (from 1 July 2025) for placing medical devices on the Great Britain market.”
More details were not provided.
This could mean that:
MDR/IVDR CE Certificates will be valid through their expiration date. And if the CE Certificate expires prior to 1 July 2025, the renewed CE Certificate can be used to maintain the UK registration until that renewed Certificate either expires or until 30 June 2030. However, if the MDR/IVDR CE Certificate expires after 1 July 2025, it may not be accepted by the MHRA, and UKCA Marking may be required instead.
That said, this is only a rudimentary interpretation based on the very brief statement made by the MHRA. We will need to wait for more information from the MHRA to better understand what exactly is meant by this statement.
Legislation must still be put into place for the above, and to formally extend the UKCA marking deadline. Currently, the guidance documents still state UKCA marking is mandatory as of 30 June 2023.