Guidance updated on future of UK medical device regulation
The government has updated guidance on the future of medical device regulation in Great Britain, stating it is aiming for the future regime of medical devices to apply from 1st June 2025.
Current regulations provide that the acceptance of CE marked medical devices on the Great Britain market will end on 30 June 2023. The government intends to put in place legislation in Spring 2023 to extend the acceptance of CE marked medical devices on the Great Britain market, which aims to support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework.
The proposed legislation will provide that CE marked medical devices may be placed on the Great Britain market to the following timelines:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
- general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030.
This will enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.
Class I medical devices and general IVDs under the Directives, for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.
If placing medical devices on the Great Britain market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).
The government also intends to introduce legislation later in 2023 to bring into force strengthened post-market surveillance requirements ahead of the wider future regulatory regime. These post-market surveillance requirements are expected to apply from mid-2024.
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.
You can read the full update from the government, here.