The current legislation, the UK Medical Devices Regulations 2002 (UK MDR), which covers both medical devices and in vitro diagnostic medical devices, reflects the previous EU medical devices directives rather than the new EU Medical Devices Regulation and In Vitro Diagnostic Device Regulation (EU MDR and IVDR). The UK MDR applies in Great Britain (England, Wales and Scotland) while the EU MDR/IVDR apply in Northern Ireland. The new UK MDR will bring UK legislation into close alignment with the EU MDR/IVDR, as well as with international standards.
The new UK MDR had been expected to come into force on 1 July 2023. However the MHRA is still drafting the new legislation based on the Government’s consultation response published earlier this year and has indicated that the new legislation will now be published in Spring 2023, with an eight week consultation period. The delay will provide industry with more time to transition existing products to the new UK regime and for more Approved Bodies (the UK equivalent of EU Notified Bodies) to become approved to ease current capacity constraints.
In short, what this means for medical device companies is:
- CE marking and certificates issued by EU Notified Bodies will continue to be recognised in Great Britain until 30 July 2024. After this date, new devices will need to be UK Conformity Assessed (UKCA) marked.
- For existing CE and UKCA marked devices, the various transition periods outlined in the Government consultation response are also likely to be extended by a year, though this has not yet been confirmed.
- Companies seeking to UKCA mark their device under the current UK MDR will now have until 30 June 2024 to do so.
The MHRA has also recently published its Roadmap for regulating Artificial Intelligence (AI) as a medical device (AIaMD) and software as a medical device (SaMD), which forms part of the UK MDR reforms. The MHRA Software and AI as a Medical Device Change Programme aims to ensure that regulatory requirements for such devices are clear and streamlined and that the devices are safe and function as intended for patients.
The Roadmap builds on the details set out in the Government consultation response published earlier this year and sets out the MHRA’s approach, which involves some changes to the legislative framework, such as to the classification rules and essential requirements for SaMD, and developing a number of guidance documents including on what qualifies as SaMD, classification of SaMD, pre- and post-market requirements and interpretability of AIaMD. The guidance will be released in tranches with the first drafts of the first tranche expected by the end of this year.
Both of the MHRA’s announcements are helpful in terms of providing more time and clarity to help industry plan the transition of devices to the new regime and future product developments. However, the granular details of the new legislation and various guidance documents remain crucial and appear some way off still. Even with the extended timeline, they will be needed sooner rather than later to support industry in implementing the upcoming changes as smoothly as possible.
We routinely advise on complex matters across the life sciences and health care sector. Please contact the author or the Hogan Lovells attorneys with whom you regularly work for specific guidance regarding regulatory issues relevant for your medical devices.
Authored by Jane Summerfield.