Update on the UKCA Mark: A Rapidly Evolving Landscape
The Medicines and Medical Devices Act 2021 gave legal power to the Medicines and Healthcare products Regulatory Agency (MHRA) to set up a new United Kingdom (UK) regulatory framework for medical devices and in vitro diagnostic devices (IVDs). This new primary legislation paved the way for the MHRA to update the existing secondary legislation - the UK Medical Devices Regulations 2002. According to the 2021 Act, new regulations must safeguard public health and, at the same time, have regard to the safety and availability of devices. The Act also means that new regulations must also make the UK a favourable place to research, develop, manufacture and supply medical devices. It is a requirement that the MHRA must carry out a public consultation before updating these and any future regulations.
In September 2021, the MHRA consulted on a new regulatory framework. In June 2022, the MHRA response outlined the UK Government policy for the regulatory framework. In general, the policy position is to align with the IVDR/MDR unless there is a reason not to. One important area where UK law might not align with European Union (EU) law is around medical devices classification. In particular, IVD and software classification may align more with the principles set out by the International Medical Device Regulators Forum (IMDRF).
In April 2023, the government announced that they were aiming for core aspects of the future regime for medical devices to apply from 1 July 2025. This new amending legislation came into force in June 2023 and gave the MHRA an extra two years to put in place the new regulatory framework. Elements that the MHRA might need to put in place include:
- Updates to legislation
- New guidance
- New registration database
- New adverse incident reporting process
The new amendment also provides transitional arrangement for acceptance of CE marked devices on the GB market . In essence, valid EU certificates and declarations for legacy devices (conforming to the old EU Directives) remain valid in Great Britain (GB) for as long as they are valid in the EU. The new legislation does not extend the validity of EU certificates and declarations in GB.
Devices complying with the EU MDR and IVDR can be placed on the Great Britain market until the 30 June 2030.
MHRA produced helpful infographics to help explain the transitional arrangements. Note that the transitional arrangements for IVDR will apply in GB but are not reflected in the infographic.
MHRA now plans new legislation for post-market surveillance to apply from 2024. Further legislation on the general regulatory framework is expected to apply from 2025. This could include further transitions for devices with the UKCA mark until 2028 or 2030.
In Northern Ireland, EU requirements for MDR and IVDR apply. This includes (EU)2023/607 extended transition periods for declarations and certificates under MDD and AIMDD and EU 2022/112 for declarations and certificates under IVDD. The revised UK regulations will not apply in Northern Ireland. Some MHRA processes (for example, adverse incident reporting and clinical investigation applications) apply across the UK, including Northern Ireland.
This is a rapidly evolving landscape and it is likely that further changes to UK laws will impact these transitions. To support UK innovation, the MHRA announced will consider expanding their role in the direct regulation of innovative devices prior to placing on the GB market. To maintain supply of safe devices, the MHRA will explore building on product regulation equivalence routes for other jurisdictions including the EU and the US. The MHRA have also stated that they will bring into force strengthened post-market surveillance requirements that are expected to apply from mid-2024. Many changes have already been implemented and further changes should now be anticipated and planned for.
Steve Lee, Director, Diagnostics Regulation, ABHI
Note: this article was originally written for BSI's Compliance Navigator for Medical Devices platform.