But in a welcome move the MHRA has confirmed an extension to certain CE-marked medical devices being placed on the GB market until at least June 2028 – some to June 2030.
Subject to approval in Parliament, the current deadline is set to be extended for devices to the following timelines:
- General medical devices compliant with the EU Medical Devices Directive (EU MDD) or the EU Active Implantable Medical Devices Directive (EU AIMDD) 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.
- In vitro diagnostic medical devices (IVDs) compliant with the EU In Vitro Diagnostic Medical Devices Directive (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, 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 GB market up until the 30 June 2030.
The government will therefore ensure that there is a proportionate – and phased – approach to the implementation of the future regulatory framework. The government now aims for core aspects of the future regime for medical devices to apply from 1 July 2025 – a two-year extension.
GOV.UK. Implementation of the Future Regulations. Available at: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations#medical-devices-regulations-webinar