Overview of Changes to UK Medical Device Markets
Since the United Kingdom (U.K.) left the European Union (EU) at the start of 2021, there have been numerous changes to medical device regulations. The Medicines & Healthcare products Regulatory Agency (MHRA) is now the sole organisation responsible for regulation and market surveillance in Great Britain (GB). An important distinction to note is that different rules now apply in GB (which includes England, Wales, and Scotland) and the U.K. (which includes England, Wales, Scotland, and Northern Ireland). The MHRA functions to assess claims of noncompliance, to monitor UK approved bodies for the purpose of assessing manufacturer compliance, and to investigate medical devices following reports of adverse events.
EU member states introduced the EU MDR and IVDR from 26 May 2021 and 26 May 2022, respectively. However, as these EU regulations did not take effect during the Brexit transition period, which ended on 31 December 2020, they were not EU law automatically retained by the EU (Withdrawal) Act 2018. Therefore, the EU medical devices regulation (EU MDR) and in vitro device regulation (EU IVDR) do not apply in GB, where devices remain regulated under the Medical Devices Regulations 2002 (UK MDR 2002).
New Route to Market for Devices in Great Britain
For medical devices in GB, there is now a new route to market and product marking known as the UKCA marking. All medical devices, including in vitro diagnostic (IVD) devices, must be registered with the MHRA before they are placed on the GB market. For manufacturers based outside of the U.K. wishing to place their device on the GB market, they must appoint a single U.K. Responsible Person, who will act on behalf of the manufacturer to perform tasks such as registration with the MHRA. UKCA marking is not recognised on the EU market. Manufacturers based in the U.K. must adhere to the relevant EU legislation and gain CE marking before placing a device in the EU market.
Legislation That Applies in Great Britain
The UK Government currently has measures in place which allow CE marked medical devices to be on the GB market to the following timelines:
- 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 GB market up until 30 June 2028 or expiry of certificate if this occurs before 30 June 2028
- IVDs compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the GB market up until 30 June 2030 or expiry of certificate if this occurs before 30 June 2030
- Medical devices compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030
Northern Ireland Regulation
As mentioned above, Northern Ireland (NI) is part of the U.K. but not GB. CE marking is still required for the NI market, as it is for EU member states, where the EU MDR and IVDR have applied since 26 May 2021 and 26 May 2022, respectively. When placing devices on the market in NI, GB-based manufacturers must appoint an EU or NI-based Authorised Representative.
Conformity Assessments and Authorised Representatives
The results of mandatory conformity assessment carried out by U.K.-based conformity assessment bodies are no longer recognised by the EU. As GB-based Authorised Representatives are no longer recognised in the EU, they are not able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market. Manufacturers based in GB or another country outside the EU must appoint an Authorised Representative based in the EU or NI if they wish to supply devices to the EU market.
UK Approved Bodies
The EU no longer recognises UK Notified Bodies, now known as UK Approved Bodies; therefore, they are not able to issue CE certificates. As of the latest update from the U.K. government on 30 January 2024, a total of nine UK Approved Bodies for medical devices have been designated.
Labelling Requirements
Manufacturers must ensure that their device meets EU labelling requirements to place it on the EU market. Both the CE marking and UKCA marking can be placed on a product so long as neither impedes the visibility of the other and both marking requirements are met. Devices placed on the NI market must meet EU labelling requirements.
Future Developments
On 9 January 2024, the MHRA published an update to the “Roadmap towards the future regulatory framework for medical devices” outlining developments that are scheduled for 2024 and 2025. Included in this roadmap are stakeholder discussions that will focus on several future core regulations including details on post-market surveillance guidance, device classification, essential requirements, labelling, Approved Bodies, and conformity assessments. The roadmap outlines that the future core regulations will be laid in parliament and subsequently put into force in 2025. Additionally, an IVD roadmap is due to be published and PMS regulations are to be laid in parliament then put in force in 2024. Moreover, the MHRA plans to publish guidance on software as a medical device (SaMD) and AI as a medical device (AIaMD), in addition to the launch of the AI Airlock in 2024, which will provide a virtual area for developers that will be regulator-monitored. The aim of the AI Airlock is to support the development of technology within the regulatory system, ensuring evidence for the safety and efficacy of their technology is generated.