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MHRA: New UK MDR now postponed to July 2024

Published by Alec Denniff, Medical Device Paralegal on

The Medicines and Healthcare products Regulatory Agency (MHRA) - the national regulator for medical devices, has issued an open letter explaining its intention to extend the standstill period for CE-marked products by 12 months to 30 June 2024. The MHRA’s letter means CE-marked devices may continue to access the UK market until this date, compared to the previous date of 30th June 2023. The extension of the standstill period also delays the start of compulsory UKCA marking. 

The MHRA first established its June 2023 deadline in guidance issued in December 2020. That guidance determined that CE marking would continue to be recognised in Great Britain until 30 June 2023, after which UKCA marking would become mandatory for manufacturers. This deadline applied irrespective of whether the device was CE marked under the EU’s MDR or IVDR, or the old MDD, IVDD, or AIMD. The guidance states that from 1 July 2023, devices placed on the Great Britain market will need to conform with UKCA marking requirements. 

The regulator’s letter will come as a relief to the med-tech industry, who have long feared that the 30 June 2023 deadline provided too short a transition period. Recently, the head of the Association of British HealthTech Industries warned that “decisive and rapid action” was needed to prevent damage to the long-term future of the UK as a place to invest and innovate. With time edging closer and closer to the deadline, and with no sign of the official UK statutory instrument to replace the UK’s Medical Device Regulations 2002 (UK MDR), it seems that the MHRA has now taken action to address these concerns. 

The MHRA states in its letter that the extra year to July 2024 will provide the necessary additional time to develop the legislation and support system readiness. This will also help ensure that the future regime is robust enough to avoid disruption to supplies, support innovation and enable safe access to medical devices for UK patients. The letter outlines plans to bring into force some post-market surveillance requirements ahead of the wider future regulations, in early 2023, emphasising the high priority that MHRA places on patient safety. 

However, industry will need to wait to see the text of the full regulations until they have been notified to the WTO and the draft published for comment under that procedure. As the UK is now outside of the EU, it is not subject to the EU’s notification procedure. Instead, the UK is required to comply with the World Trade Organisation’s Technical Barrier to Trade agreement. This means the UK’s regulator must notify the WTO and publish its draft regulations for a period of at least 60 days before the regulations are laid within Parliament. The MHRA suggests that this will provide enough opportunity for stakeholders to review and comment on the draft legislation before it enters into force. 

The MHRA’s letter also discussed the capacity concerns across the UK Approved Body (UKAB) system. Prior to the designation of DEKRA Certification UK at the end of September, the UK had three Approved Bodies. Whilst DEKRA’s designation takes that number to four, the MHRA appears to be aware of capacity constraints, and the letter notes that they are currently “working proactively with six other organisations who have applied to become UKABs, and several more who have expressed an interest in being designated.” Should these discussions materialise in successful designations, the UK would have roughly ten UKAB’s – a number more aligned with the work expected to come from the entry into force of the new regulations. 

Manufacturers who do not already have a CE mark or UKCA mark in place should consider whether they can achieve a UKCA mark before the new regulations come into force under the present UK MDR, or whether they should align towards the new regulations. The former would enable them to benefit from the transitional periods (which will now begin in July 2024). Although there is some risk with the latter approach, due to the lack of certainty about the final form of the regulations, it is likely to reduce the duplication of regulatory work.