On 27 April 2023, the MHRA announced that the UK government intends to introduce legislation this spring that will extend the acceptance period of CE marked devices onto the Great Britain market. The MHRA’s announcement has provided much needed. This statement made by the MHRA is an update to their announcement made on 28 March 2023, on which we previously blogged.
This is a very welcome step from the MHRA after what has been a period of great challenge and uncertainty for pan-European medtech companies operating in the UK and the EU; on 28 April 2023 the ABHI greeted the move, commenting that the intended extension of transition periods and the continued recognition of CE marking will enable the UK government to put into place a future regulatory system that is both practical and suitable for the healthcare industry.
Subject to parliamentary approval, the MHRA intends to introduce legislation before 30 June 2023 which will allow CE marked devices – approved under both the old Directives and the new Medical Devices Regulation respectively – to be placed on the GB market to the following timelines:
- General medical devices that are compliant with the EU medical devices directive or EU active implantable medical devices directive, with a valid declaration and CE marking, can be placed on the GB market up until the sooner of expiry of certificate or 30 June 2028
- IVDs that are compliant with the EU IVDD can be placed on the GB market up until the sooner of expiry of certificate or 30 June 2030
- General medical devices, including custom-made devices, which are compliant with the EU MDR, and IVDs which are compliant with the EU IVDR, can be placed on the GB market up until the sooner of expiry of certificate or 30 June 2030
These timelines will allow CE marked medical devices to be placed on the GB market for a longer period. Under the transitional measures, when placing medical devices on the GB market, manufacturers will not be able to rely on expired certificates, unless these certificates have been otherwise deemed valid by the EU.
The MHRA has also announced the government’s intention to introduce legislation later in 2023 that will bring into force strengthened post-market surveillance requirements, ahead of the wider future regulatory positions. These post-market requirements are anticipated to apply from mid-2024. The ABHI is engaged in discussions with the government regarding this, and welcomes thoughts as to how these requirements can be suitably applied.
For further information please contact Jaspreet Takhar, Elina Angeloudi or Julia Gillert.