MedTech Europe, the Association of British HealthTech Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA) have welcomed the UK Government’s decision to indefinitely recognise CE-marked medical devices and in vitro diagnostic medical devices in Great Britain.
The decision was announced by the Medicines and Healthcare products Regulatory Agency (MHRA), and the three organisations describe it as a foundational step in the ongoing reform of the UK medical device regulatory framework. 1792999272206
Continued Market Access for CE-Marked Devices
According to the joint statement, indefinite recognition is expected to support continued patient access to essential medical technologies, including:
medical devices;
IVDs;
digital health technologies;
AI-enabled technologies. 1792999272206
The organisations also argue that the decision should provide greater regulatory predictability for manufacturers operating across the UK and EU markets.
Reduced Regulatory Divergence
The statement places particular emphasis on the highly integrated nature of the EU–UK medical technology sector.
Manufacturers and healthcare systems depend on:
interconnected supply chains;
cross-border trade;
regulatory cooperation.
The organisations argue that avoiding unnecessary regulatory divergence is important to maintaining uninterrupted access to medical technologies. 1792999272206
Continued Recognition of MDR and IVDR Compliance
The decision means that devices compliant with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will continue to be recognised in Great Britain.
MedTech Europe, ABHI and BIVDA describe this as a pragmatic and proportionate approach because these products have already undergone assessment under the EU regulatory framework. 1792999272206
The organisations argue that continued recognition helps maintain safety and performance standards while avoiding unnecessary duplication of regulatory processes.
Implications for Manufacturers
For manufacturers supplying both the EU and Great Britain markets, the decision could significantly improve regulatory predictability.
Potential benefits include:
reduced need for duplicative conformity assessment;
greater continuity between EU and UK regulatory strategies;
lower administrative burden;
more predictable market access;
reduced risk of supply disruption.
The statement also links the decision to broader goals around innovation and investment in the UK medical technology sector. 1792999272206
Impact on IVD Manufacturers
The decision is particularly relevant for IVD manufacturers, many of whom are already managing the transition to the EU IVDR.
Continued recognition of CE-marked IVDs in Great Britain may help manufacturers maintain a more aligned regulatory strategy across both markets rather than operating completely separate pathways.
BIVDA’s participation in the joint statement also highlights the importance of the decision for the diagnostics sector.
Impact on Digital Health and AI
The statement explicitly includes digital healthcare and AI among the technologies expected to benefit from continued CE recognition. 1792999272206
For developers of software and AI-enabled medical technologies, this could provide greater certainty when planning market access strategies across the EU and Great Britain.
Industry Welcomes MHRA Engagement
MedTech Europe, ABHI and BIVDA also welcomed the MHRA’s engagement with industry during the consultation process.
The organisations state that they intend to continue working with MHRA to support and monitor implementation of the decision. 1792999272206
They also highlight the importance of clear guidance for manufacturers.
Continued UK–EU Regulatory Cooperation
The statement concludes by stressing that regulatory cooperation between the UK and EU will remain important.
According to the signatories, continued cooperation can help ensure a more resilient supply of safe and effective medical technologies for patients, healthcare professionals and healthcare systems. 1792999272206
What Manufacturers Should Monitor
Although the decision provides important regulatory certainty, manufacturers should continue to monitor:
MHRA implementation guidance;
registration requirements in Great Britain;
UK Responsible Person obligations;
labelling requirements;
post-market surveillance;
vigilance;
future UK MDR reforms;
any conditions attached to recognition of CE-marked products.
The practical implementation details will be critical for understanding how indefinite recognition operates in day-to-day regulatory practice.
Impact on the Medical Technology Sector
For the wider medical technology sector, indefinite recognition of CE-marked devices represents a significant shift toward greater regulatory continuity between the EU and Great Britain.
For companies already operating under MDR and IVDR, the decision may reduce duplication and support more efficient market access planning.
It may also help mitigate supply risks by allowing manufacturers to continue leveraging EU conformity assessment for access to the Great Britain market.
