Consolidated text of UK Medical Devices Regulations released

Current UK MDR now available online in single document

The EU Medical Devices Regulation (MDR), EU 2017/745, and In Vitro Diagnostic Medical Devices Regulation (IVDR), EU 2017/746, were not implemented in Great Britain, i.e., England, Scotland and Wales. Northern Ireland has a special status as EU rules will continue to apply there.

The UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) implement the Directives for active implantable medical devices, medical devices and in vitro diagnostic medical devices (IVDs). The UK MDR continues to have effect in Great Britain. These regulations have undergone several amendments since they came into effect in 2002. Amendments were incorporated to implement into UK law changes that were made in the European Directives after 2002. In addition, further amendments were added to make the regulations effective in the UK following Brexit by cutting the links with European Institutions and bringing certain responsibilities under national jurisdiction. 

One problem that many organizations encountered in making sure that they could understand the regulatory requirements for Great Britain was that an official, consolidated text of the UK MDR was not available showing all the amendments that have been implemented in a single document.  That has now been rectified with a consolidated version of the current UK MDR being uploaded to the official website (legislation.gov.uk). The website indicates that the Medical Devices Regulations 2002 is up to date with all changes known to be in force on or before 06 April 2022.

The website also indicates that there are changes that may be brought into force at a future date. The Medicines and Medical Devices Act 2021 is enabling legislation that provides the authority to amend or supplement the law for medical devices. The UK Medicines and Healthcare products Regulatory Agency (MHRA) have completed a consultation exercise on future UK regulations. The MHRA have indicated that they plan to introduce the new regulatory regime at the beginning of July 2023 to align with the date from which the UK is due to stop accepting CE marking for medical devices in Great Britain. The current position is that the UK will continue to recognize European CE marking until 30 June 2023.

Time is short for this deadline for new UK regulations and currently no proposals have been made available. The legislative process has not yet started. The authority in the Medicines and Medical Devices Act is to amend or supplement the existing regulations rather than replace them, so the availability of the current requirements in a consolidated form is helpful.

Manufacturers will want to follow the development of new regulatory requirements for the UK. In particular, they will need to understand any transition provisions for the new UK regulatory requirements, given the stated deadline for the end of acceptance of CE marking in the UK.