The extension of the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) standstill period for CE-marked devices distributing on the Great Britain (GB) market was declared near the end of April, giving new transition deadlines of more than the one extra year.
The original deadline of July 1, 2023 was inadequate and the MHRA assured the standstill period would be extended by one year during which CE-marked can be used on the GB market. Industry felt that another year was still inadequate. The legislative basis of the UK’s sovereign devices regulatory system as an outcome of Brexit is expected to be formed of three statutory instruments (SIs).
In the MHRA guidance on the draft SI published 27 April, there is no mention of 1 July 2024 deadline and the MHRA says that the government are aiming at having 1 July 2025 as the deadline for all the crucial features of the future rule for medical devices.
The draft SI was now recently approved at the end of June where the government allows for longer transition times for the use of CE-marked devices in GB, that is before the obligatory use of UKCA marked products only:
- 30 June 2028 (or expiry of certificate, whichever is first) for general medicinal devices satisfying the EU Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD).
- 30 June 2030 for in vitro diagnostic medical devices compliant with the In Vitro Diagnostic Directive (IVDD).
- 30 June 2030 for general medical devices, including custom-made devices, compliant with the MDR and IVDs compliant with the IVDR.
Further guidance was published on device registrations:
Expired CE certificates: Requirement to upload a letter declaring compliance with extended validity under the MDR;
Up-classified class I devices: Requirement to monitor the MHRA website for updates. Current MHRA registration will need to be updated by June 2028.
Source: Medtech Insight (an Informa product)