Europe: 2022 Recap & 2023 Look ForwardJanuary 4, 2023
EU Commission Releases Official Proposal to Extend the MDR Transition PeriodJanuary 6, 2023
Here we will look back at the UK regulatory changes and announcements from 2022 and look forward to the important deadlines and anticipated announcements for 2023.
NOTE: The 2022 recap is not exhaustive; it includes the updates that may be interesting to a wide pool of manufacturers.
More information on the below topics can be found in our: UK Regulatory Updates
NOTE: The UK is made up of four countries and all have left the European Union.
- Great Britain (England, Scotland, and Wales) requires a UK Responsible Person (UKRP). Further, Great Britain will (eventually) no longer accept CE Marking; instead, UKCA Marking will be required.
- Northern Ireland will remain in the European Single Market. Therefore, it requires CE Marking and an EU Authorized Representative. Northern Ireland will not recognize UKCA marking or UKRPs.
- The “Brexit” transition period to appoint a UK Responsible Person (UKRP) and register with the MHRA ends for all devices. The MHRA continues to accept CE Marking.
- The MHRA provided the following timeframes to comply:
- Class III, AIMD, Class IIb implantable; IVD Annex II, List A devices until May 1, 2021
- Class IIb non-implantable, Class IIa; IVD Annex II, List B, IVD self-test until September 1, 2021
- Class I, custom-made and general IVD devices until January 1, 2022
- The MHRA updates SGS’s UK Approved Body scope, to remove device category MD 0110 (non-active medical devices for ingestion) and Annex VII (production quality assurance).
- IVDR date of application arrives: 26 May 2022
- The IVDR’s date of application may have an impact on UK registrations. If a manufacturer registered their IVD based on their CE Marking, and the CE Marking was updated from IVDD ‘other-general’ to IVDR Class A, the MHRA registration should have been updated accordingly.
- The UK government releases its response to the new draft medical device/IVD regulation. In it, the MHRA confirms they intend to introduce a transition period for UKCA marking.
- The MHRA proposes to continue recognizing CE Marking for:
- MDR/IVDR/IVDD CE Marked devices – additional five years after the new UK regulation goes into effect
- MDD/AIMDD CE Marked devices – additional three years after the new regulation goes into effect
- The proposed new Medical Device Regulation will be aligned to the MDR/IVDR in many, but not all respects.
- EU Commission launches infringement procedures against the UK, citing non-compliance with the Northern Ireland Protocol. This potentially puts the Protocol at risk, in which Northern Ireland remains part of the European Single Market and allows an easier movement of goods between the UK and the EU.
- Any further repercussions unknown at this time, although both sides have expressed a wish to amicably resolve the issues.
- MHRA proposes a fee increase, with a proposed implementation date of April 1, 2023.
- The impact on medical device & IVD:
- Registration (new & modification) is from £100 to £240
- Clinical investigation notification from £2,920-£5,040 to £5,711-£15,627
- The MHRA appoints DEKRA Certification UK Ltd as a new UK Approved Body. This is the first new UK Approved Body to be appointed since “Brexit” and brings the total number to four.
- The other three (BSI, SGS, and UL) were formerly UK-based Notified Bodies that were grandfathered in as UK Approved Bodies post-Brexit.
- The MHRA announces that:
- The new Medical Device Regulation and the UKCA marking compliance deadline will both be postponed by one year:
- From July 2023 to July 2024
- They will institute the CE marking/UKCA marking transition period, as mentioned in June. With this, the new transition timeframes are:
- MDR/IVDR/IVDD CE Marked devices – accepted for an additional five years after the new UK regulation goes into effect, i.e., July 2029
- MDD/AIMDD CE Marked devices – accepted for an additional three years after the new regulation goes into effect, i.e., July 2027
- UKCA Marked medical devices (to the current version of regulation) – additional three years to comply with the new regulation, i.e., July 2027
- UKCA Marked IVDs (to the current version of the regulation) – additional five years to comply with new regulation, i.e., July 2029
- The MHRA updates its vigilance process, to take effect starting November 21, 2022.
- Updates include:
- Manufacturers must register in the MHRA’s new version of their ‘MORE’ online portal
- Obsoletes the ability to email reports – the last date to do so will be April 30, 2023; instead, manufacturers to submit either through the new MORE online portal, or contact the MHRA to implement direct submission through an API connector
- The MHRA updates its guidance to more explicitly clarify that Manufacturers/distributors may not:
- Make claims that UK registration constitutes “any form of accreditation, certification, approval or endorsement by the MHRA”
- Use the MHRA’s logo in “any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation.”
2023 Look Forward
We can anticipate more information released about the proposed new Medical Device Regulation – including more information about the post-market surveillance requirements they intend to introduce before the new regulation goes into effect. Hopefully, also the designation of additional UK Approved Bodies, although that becomes less urgent now that the UKCA Marking deadline has been postponed with a further transition period added.
Otherwise, no major regulatory overhauls or critical deadlines are expected in the UK for 2023. Famous last words?