MHRA announces changes to medical device regulations
Posted on the 28th April 2023
The UK’s medical regulator, the MRHA, has announced new details relating to the implementation of revised medical device regulations.
The body is aiming for core aspects of the future regime to be in place by July of 2025 and includes transitional arrangements.
The move marks a substantial reform of the current regulatory framework for medical devices in the UK. However, the government has said the shift will be proportionate and phased to minimize the risk of supply disruption for patients.
Under the current Medical Device Regulations 2002 the acceptance of CE marked medical devices on the Great Britain market will end on 30 June 2023.
However, subject to Parliamentary approval, the government intends to introduce legislation that will extend the acceptance of these medical devices on the GB market and should ease the transition to the future regulatory framework for medical devices.
These proposals would ensure that 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 end of June 2028.
Meanwhile, in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) and custom-made devices, complaint with the EU medical devices regulation (EU MDR) could remain on the Great Britain market until June 2030.
The moves will be mean that Class 1 medical devices 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 (i.e., if it is an unclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.
Furthermore, if placing medical devices on the Great Britain market under these transitional measures, manufacturers will not be able to rely on expired certificates (unless such certificates have been otherwise deemed valid by the EU).
Later this year, the government intends to introduce legislation that will bring into force strengthened post-market surveillance requirements ahead of the wider future regulatory regime.
This is in line with its priority of improving patient safety as part of the future medical device regulations. These post-market surveillance requirements are expected to apply from mid-2024.
The changes will also mean that it will not be possible to rely on EU MDR or EU IVDR CE certificates that are renewed after the future regime fully applies (from 1 July 2025) for placing medical devices on the Great Britain market.