A statutory instrument has been laid in Parliament, which will enable an extended time-frame for the acceptance of CE marked medical devices on the Great Britain market and also a new date of implementation of the future UK Medical device regulations, in which the new regulatory framework will now apply from July 2025.
The length of time that CE marked devices will be accepted in the UK has also been extended as follows:
- 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
- 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.
Regarding class I 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. Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.
Concerning the government’s intention to strengthen post market surveillance requirements these are also delayed with the new requirements expected to apply form mid-2024.
These changes are subject to Parliamentary approval.
Full details on the new medical device regulations can be found here Implementation of the Future Regulations – GOV.UK
Patrick Trotter PhD, MBA(Techmgmt)
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