The UK government is planning a substantial reform of the current regulatory framework for medical devices in the country. In response to the 2021 consultation on the future regulation of medical devices in the UK, the government has outlined its approach to this reform. The government plans to ensure a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimizes the risk of supply disruption for UK patients.
The UK government has updated its guidance to reflect that it is now aiming for core aspects of the future regime for medical devices to apply from 1 July 2025. The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) currently provide that the acceptance of CE marked medical devices on the Great Britain market will end on 30 June 2023. However, the government intends to extend the acceptance of CE marked medical devices on the Great Britain market by putting in place legislation in Spring 2023. This will support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework for medical devices.
Subject to Parliamentary approval, the government intends to introduce legislation before 30 June 2023 which will provide timelines for certain CE marked medical devices to be placed on the Great Britain market. This includes 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, which 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. 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 30 June 2030.
The government also intends to introduce legislation later in 2023 that will 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.
To support the effective implementation of the new regime, the UK government is working with industry, trade associations, and the wider medical devices community. Regulatory changes will be accompanied by guidance to support the MedTech sector in the interpretation of the new regulatory requirements.
If you want to learn more about the Medical Devices Regulations, you can view the recording of the Medical Devices Regulations webinar which took place on Tuesday 24 January 2023. Stay updated with the UK government’s plans for the future regulations of medical devices to ensure a safe supply of medical devices to UK patients.
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