Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.

Transitional Periods

As noted in our previous post, the UK government’s approach to a proportionate implementation of the regulatory reform was outlined in its response to the 2021 consultation on the future regulation of medical devices. The proposed transitional periods under the UK Regulations will be 3 years for standard devices that are on the market with a UKCA mark and 5 years for in vitro diagnostic medical devices (IVDs) that are UKCA marked. Given the government’s intention for the UK Regulations to apply from 2025, these periods will be until 30 June 2028 for standard devices and 30 June 2030 for IVDs.

In relation to devices that are on the market with an EU CE mark, the Medical Device Regulations 2002 (UK MDR) currently state that EU CE marked medical devices can be placed on the Great Britain market until 30 June 2023. However, the MHRA announced in October 2022 that the deadline would be extended by an additional 12 months to 30 June 2024.

Most recently, the government has proposed new legislation (the Medical Devices (Amendment) (Great Britain) Regulations 2023), that, once adopted, will extend the period of acceptance of valid EU CE marked medical devices in Great Britain to support the continued safe supply of medical devices and to ease the transition to the new, incoming UK regulatory regime.

In summary, the new transitional periods will allow valid EU CE marked medical devices to be placed on the market in Great Britain as follows (although there are additional details in the draft):

  • Until 30 June 2028: medical devices compliant with the old EU regime under the EU MDD or EU AIMDD with a valid declaration and CE marking
  • Until 30 June 2030: IVDs compliant with the old EU regime under the EU IVDD
  • Until 30 June 2030: general medical devices, including custom-made devices, compliant with the new EU regime under the EU MDR and IVDs compliant with the EU IVDR

In addition:

  • Class I medical devices and general IVDs under the EU MDD or EU IVDD, where conformity assessment did not require the involvement of a notified body, but which can only be placed on the market with the involvement of an EU notified body under the EU MDR or IVDR (i.e., up-classified devices such as software), can continue to be placed on the GB market until 30 June 2028
  • Class I devices under the EU MDR can be placed on the Great Britain market until 30 June 2030
  • Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market

Particularly important to companies is the fact that manufacturers will be able to rely on expired EU MDD certificates to place medical devices on the Great Britain market where these have been deemed valid under the EU MDR, via the applicable EU transitional periods and assuming the relevant conditions have been met. See our previous post for further information on the EU transitional periods.

MHRA guidance states that a further amendment is intended that will mean that, once the UK Regulations apply in July 2025, it will not be possible to rely on renewed EU CE certificates under the EU MDR or EU IVDR.

This legislation is currently awaiting approval by the UK parliament, although is proceeding through the process quickly. Stakeholders should review the new rules carefully to ensure they understand which rules will apply to their devices/IVDs, and to ensure they can lawfully rely on these transitional periods; notably this is determined by both the classification of the device and which EU legislation the device currently complies with (either the old regime or the new regime under the EU MDR/ EU IVDR).

Innovative Devices Access Pathway (IDAP)

The IDAP is a pilot for a new regulatory pathway that aims to facilitate the development of innovative technologies and support safe – and quick – patient access to such technologies. The IDAP will be run by the MHRA, the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG).

The IDAP pilot phase will be used to research, design and scope an innovative access pathway for selected medical and digital health technologies. NICE has stated that the pathway will be available for technologies that:

  • are new and innovative
  • meet critical unmet needs in the health and care system
  • have the support of an NHS organisation or network
  • meet relevant safety standards

Innovators and manufacturers will be provided with a multi-partner support service (involving the MHRA, NICE and the devolved administrations) with the aim of providing enhanced opportunities for engagement and targeted scientific advice. The IDAP will help innovators generate evidence that meets the needs for the UKCA marking process and to consider the needs of the health technology assessment process early in the development pathway. IDAP will also offer post-market access support.

Interested companies can register for further information ahead of the planned 2023 pilot launch here:


This legislation has been finalised as the Medical Devices (Amendment) (Great Britain) Regulations 2023/627 and this infographic has been published to assist with identifying the new periods.