Sharon Lamb, McDermott Will & Emery, partner, London and Bella North, McDermott Will & Emery, associate, London update on the latest for UKCA requirements and new medical device regulations.
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On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention:
- To extend the current standstill period by 12 months from July 2023 to July 2024. This means that valid CE marks would continue to be accepted in Great Britain (GB) and the requirement to obtain a UK Conformity Assessed (UKCA) mark has been delayed until July 2024; and
- To introduce the new medical device regulations in July 2024.
This news will come as welcome relief to manufacturers in the sector following widely published reports of a backlog in processing UKCA applications at approved bodies across the UK.
Importantly, the extension is not yet confirmed by law, so we expect further updates to the MHRA website and new legislation to be issued.
This extension was widely expected following delays in introducing the new medical device regulatory framework.
The specific details of the new UK medical device framework have yet to be published following the UK government consultation on the proposed changes which began in 2021. The government response to the consultation published in June 2022 indicated that the new GB medical device regulations will be closely aligned the EU Medical Device Regulations 2017.
The MHRA timetable for implementation initially contemplated that the consultation response for the new framework would be published in March 2022 with the regulations laid before parliament by the end of June 2022. Under World Trade Organisation (WTO) rules, the MHRA is also required to notify the WTO and the WTO must publish the draft regulations for a period of at least 60 days for comment before the regulations are laid.
The MHRA has said that it continues to work on the development of the future regulations. The likely timeline appears to be:
- New medical device regulations notification to WTO: early 2023
- New medical device regulations laid before parliament: Spring 2023
- New post-market surveillance requirements: Spring 2023
- New medical device regulations come into force: July 2024
- Timeline for new transitional periods commence: July 2024.
The government response in June 2022 indicated that there would be fairly generous transitional periods in the new medical device framework. The response said that the arrangements would allow, at a minimum, products to be placed on the market as follows:
- General medical devices: until either the certificate expires or for three years after the new regulations take effect (whichever occurred sooner); and
- In Vitro Diagnostics: until either the certificate expires or five years after the new regulations take effect (whichever is sooner).
These transitional provisions would not apply if there were significant changes in design or intended purpose. In addition, all products which benefit from transitional arrangements are likely to need to comply with the post-market requirements.
In its letter on 21 October 2022, the MHRA also acknowledged the shortage of UK approved bodies and noted that it was proactively working with six organisations that have applied to become UK approved bodies. Currently, there are only four designated UK approved bodies.
This news also comes in the week that the MHRA also released guidance on Software and AI as Medical Device Change Programme Roadmap setting out proposals to implement new legislation and further guidance intending to clarify what medical device requirements mean in the context of software and AI and more closely align with global rules such as the IMDRF.
