Since the UK left the European Union, medical devices have been regulated by the Medical Regulations 2002 (UK MDR 2002). Although a new route to market and product marking (the UKCA marking) is available for manufacturers wanting to place medical devices on the Great Britain market, the plan had been to recognize CE marking until 30 June 2023, the day before the new UK Medical Device Regulation had been expected to come into force. With the new regulation now delayed a year to July 2024, the MHRA has published its intention to extend the deadline on CE marking recognition to 30 June 2024.
What has changed?
The future UK MDR introduces significant changes to the current regulatory framework. Although the specific details of the new regulation have not been published yet, the consultation conducted in 2021 and the government response to the consultation published in June 2022 show the intention to largely align the UK regulations with the EU MDR / IVDR, with some differences, such as requirements for software.
Considering the delay in publishing the regulation (no draft is available yet) and the difficulty for manufacturers to secure an assessment from one of the 4 UK Approved Bodies, the MHRA has extended the standstill period – when devices in the UK can still bear CE marks — by 12 months.
In addition, the MHRA published their roadmap for software and AI as a medical device. This program of work, which aims to ensure regulatory requirements are clear and patients are safe, includes 11 work packages – 8 for software as a medical device and 3 for AI as a medical device. These will help manufacturers of such devices to comply with the future UK MDR.
What happens next?
At the end of 2022, publication of the first tranche of software and AI guidance is expected. This covers intended purpose, review of adverse incident signal detection, regulatory guidance on good machine learning practice, best practice guidance on AI as MD for all, guiding principles on adaptivity and change management in AI.
From late 2022 into early 2023, MHRA is expected to publish its amendment to guidance on the regulation of medical devices in the UK to reflect the changes in timelines described above.
Before spring 2023, the amendment of the current legislation (UK MDR 2002) to implement transitional arrangements and post market surveillance requirements is expected. The proposed post market requirements are aligned with EU MDR/IVDR and will be applicable to all devices from 1 July 2023.
Other key timelines include:
2023 — Draft UK MDR to be published and open for consultation (for 2 months).
2023 — UK MDR submitted to Parliament.
1 July 2024 — the new UK MDR enters into force.
July 2024 to July 2029 — Transitional arrangements for conformity to the future UK MDR for devices currently CE and UKCA marked.
The timelines proposed in the government response are:
For devices UKCA marked under UK MDR 2002 or CE marked under EU directives (MDD, AIMD or IVDD): until their certificate expires or for 3 years (medical devices) or 5 years (In vitro diagnostic medical devices) after the new regulation enters into force, whichever is sooner.
For devices CE marked under EU MDR/IVDR: until their certificate expires or for 5 years after the new regulation enters into force (i.e. until 2029), whichever is sooner. Devices with certificates / declaration of conformity issued after July 2024 can benefit from that arrangement.
What does it mean for manufacturers and devices?
- CE marked devices will be accepted on the Great Britain market until 30 June 2024.
- The requirement to obtain a UK CA marking and the implementation of the new UK MDR are delayed until 1 July 2024 for new devices, with further transitional arrangements available to devices CE marked or UKCA marked.
- Manufacturers will need to apply updated post-market requirements from July 2023 (1 year before the rest of the new UK MDR).
- Devices that are subject to significant changes in design and intended purpose cannot benefit from the transitional arrangement after July 2024 and will need to comply with the new UK MDR.
Reference:
