CE Mark transition
Under the current UK MDR, CE marked devices can be placed on the market in Great Britain until 30 June 2023. The MHRA announced in October 2022 that this standstill period would be extended by 12 months to 30 June 2024, but the UK MDR has not yet been amended to reflect this. The MHRA’s update confirms that, subject to parliamentary approval, legislation implementing the amended date will be in place by the end of June 2023.
The update also confirms that EU CE certificates, including where these have been extended under the recently revised EU Medical Devices Regulation (EU MDR) and EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR) transitional arrangements, can be relied on for placing a medical device on the market in Great Britain and Northern Ireland.
This means that CE marked medical devices can continue to be placed on the market in GB as follows:
medical devices that comply with the EU Medical Devices Directive (EU MDD) or EU Active Implantable Medical Devices Directive (EU AIMDD) with a valid declaration and CE mark can be placed on the GB market until the earlier of certificate expiry or 30 June 2028;
in vitro diagnostic medical devices (IVDs) that comply with the EU In Vitro Diagnostic Medical Devices Directive (EU IVDD) can be placed on the GB market until the earlier of certificate expiry or 30 June 2030;
medical devices that comply with the EU MDR and IVDs that comply with the EU IVDR can be placed on the GB market until the earlier of certificate expiry or 30 June 2030.
Class I medical devices and general IVDs where the conformity assessment under the EU MDD/AIMDD/IVDD did not involve a notified body can only be placed on the Great Britain market under the transitional periods above if the involvement of a notified body would be required under the EU MDR or IVDR.
The update also states that when the reforms to the UK MDR (see below) have been made, it will no longer be possible to rely on EU MDR/IVDR certificates that are renewed after that date, meaning the device will need to comply with the UK MDR including UKCA marking.
The MHRA has also published new guidance on registering devices in the UK where they are reliant on an expired CE certificate that is deemed valid under the EU MDR transitional arrangements. As part of the registration, the MHRA requires a letter declaring that key conditions for extension of the certificate under EU MDR Article 120 have been met, using the MHRA’s template letter.
Timing of UK MDR reforms
In addition to legislation to amend the UK MDR transitional arrangements outlined above, the government will take a phased approach to implementing the reform of the UK MDR which was consulted on in 2021/22.
As the next step, the MHRA intends to publish legislation later in 2023 to bring into force strengthened post-market surveillance requirements, likely from 1 July 2024. Further legislation will then be put forward to implement the other reforms, with the update stating that the government is aiming for “core aspects” of those reforms to the UK MDR to apply from 1 July 2025.
The government also confirmed that new guidance will be published to support industry with interpreting the new UK MDR requirements.
The announcement provides reassurance that the UK MDR will be amended to reflect the previously announced 12-month extension and clarity on the interplay between recent developments at EU level to the EU MDR/IVDR transitional arrangements with the UK MDR transitional arrangements. However, it also raises the question as to what might fall outside the “core aspects” of the reforms and therefore potentially be deferred beyond mid-2025 and does not touch on when the models for recognising devices approved in other trusted jurisdictions announced in the Chancellor's recent Budget speech will be in place.
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Authored by Jane Summerfield.