9th May 2023

Implementation of the future Medical Device Regulations

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.

Please click here to read the full article by Patrick Trotter PhD, MBA(Techmgmt) on the Medilink North of England website.