Implementation of revised UK Medical Devices Regulations delayed

MHRA announced a twelve-month delay to develop the legislation and prevent supply disruption

Following the end of the Brexit transition period, the EU Medical Devices Regulation (MDR), EU 2017/745, and In Vitro Diagnostic Medical Devices Regulation (IVDR), EU 2017/746, were not transposed into law in Great Britain. In this context, it is important to be aware of the distinction between Great Britain – England, Scotland and Wales – and the United Kingdom (UK), which comprises Great Britain and Northern Ireland. The MDR and IVDR will not be implemented in 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) implement the Directives for active implantable medical devices, medical devices and in vitro diagnostic medical devices (IVDs) in the UK. A consolidated version of the current UK MDR has been 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 16 November 2022. 

The Medicines and Medical Devices Act 2021 provides the authority to amend or supplement the law for medical devices. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has completed a consultation exercise on future UK regulations and published the Government response to the consultation. The MHRA originally indicated that they were planning to introduce the new regulatory regime at the beginning of July 2023, but the implementation of the planned amendment to the medical device regulations has been officially delayed by 12 months. This delay is to avoid potential supply disruptions and to allow additional time to prepare the necessary systems and processes. The MHRA announcement extends the deadline to July 2024 for launching the transition from CE Mark to UKCA certification of medical devices in Great Britain. Manufacturers will be able to continue to place CE marked devices on the Great Britain market after 1 July 2023. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.

The announcement outlines an intention to initiate the legislative process to amend the UK regulations by Spring 2023. The legislation will bring into force transitional arrangements that would allow products to be placed on the market until either the European Directives or current UKCA certificate expires or for three years after the new regulations take effect (in the case of medical devices) or five years (in the case of IVDs), whichever is sooner.

The MHRA announcement also indicates that the new legislation will bring into force new post-market surveillance requirements, as outlined in the government response to the consultation, ahead of the wider future regulatory regime.

Manufacturers should consider the effect of this announcement on their transition plans. In particular, it is worth checking the dates of expiry of certificates and declarations of conformity to the EU Directives for active implantable medical devices, medical devices and IVDs. Given the current number of UK Approved Bodies designated for conformity assessment under UKCA scheme and the experience of the transition to the EU MDR and IVDR, it remains to be seen if this additional year on top of the transitional arrangements will provide sufficient time. Nevertheless, hoping that deadlines could be delayed further is an unwise strategy to plan transition. Manufacturers should develop their plans based on the available information on timelines, while monitoring for updates on the developing legislation and supporting guidance.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development