In June 2023, the UK passed new legislation, SI 2023 No.627, extending the acceptance of CE-marked devices in the Great Britain (GB) market. The regulations cover medical devices and In Vitro Diagnostic (IVD) products and provide revised timelines as follows:
- MDD/AIMD: Devices with a valid declaration and CE mark can be accepted until 30 June 2028 or until certificate expiry, whichever occurs soonest.
- IVDD: Devices compliant with IVDD can be accepted until 30 June 2030.
- MDR/IVDR: Devices compliant with MDR/IVDR can be accepted until 30 June 2030.
This extension aligns with the Medicines and Healthcare Products Regulatory Agency’s (MHRA) previous communication in April, taking into account the transitional timelines in Europe. Previously, CE-certified medical devices could only be placed on the GB market until 30 June 2023, so this legislative change provides significant flexibility. The extended timeline allows manufacturers to prioritize the transition to MDR/IVDR in Europe before transitioning to the new UKCA system, creating a clear separation between the two timelines. It also grants additional time for the development of the UKCA system and the necessary resources for UK conformity assessment bodies. This infographic illustrates the timelines for acceptance of MDD, AIMD, MDR and IVDR certification.
The MHRA has also published guidance on certain device registrations, outlining conditions and instructions for specific scenarios. Key points include:
- Expired CE Certificates: Manufacturers must upload a letter declaring compliance with extended validity under the MDR.
- Up-classified Class I Devices: No immediate action is required for currently registered devices, but manufacturers should monitor the MHRA website for updates. Current MHRA registration will need to be updated by June 2028.
- Northern Ireland (NI): Different timelines apply for the NI market compared to the GB market.
Additionally, there is strengthening of Post-Market Surveillance (PMS) requirements, as the MHRA guidance indicates plans for additional regulations to enhance PMS requirements, which are expected to be implemented from mid-2024.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of Medical Device and IVD experts communicate with EU entities nearly every day and are the most experienced in the industry at accelerating regulatory submissions and approvals for manufacturers. Many of our Associates have previously held positions within these organizations, which provides Clients with the benefit of a more precise understanding of how to proactively plan for international requirements and expectations.
Make sure you’re on the right track! If you are interested in scheduling a complimentary consultation with one of our EU MDR experts, we invite you to do so here: https://namsa.com/namsa-expertise/subject-matter-experts/.
Jane Arnold-Round has 30 years’ experience in the medical device industry working with a broad range of medical device technologies and organisations from start-ups to multinationals. She was a Notified Body reviewer for over 15 years having worked for BSI as a medical device product specialist with particular responsibility for the wound care sector, device-drug combinations medical device utilising animal tissues. A regulatory consultant for 17 years, she joined the medical device consulting team at NAMSA in 2018 and currently serves as a Senior Principal Regulatory Consultant.