The UK government has confirmed plans to recognise CE-marked medical devices and in vitro diagnostic devices (IVDs) indefinitely in Great Britain. The decision provides greater regulatory certainty for manufacturers and supports continued access to medical technologies for patients and healthcare providers.
On 21 October 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the government’s decision following a public consultation involving more than 1,000 responses from industry, healthcare professionals, patients and other stakeholders.
The decision represents an important development in the UK’s post-Brexit medical device regulatory framework, reducing the risk of duplicated approval processes for manufacturers already complying with European requirements.
What does indefinite CE-mark recognition mean?
Under the government’s planned approach, medical devices and IVDs that comply with the EU Medical Device Regulation (MDR 2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746) will continue to be recognised for access to the Great Britain market without a fixed end date.
This means manufacturers with qualifying CE-marked devices will not need to obtain an additional UKCA conformity assessment solely to access the Great Britain market.
The UKCA marking route will remain available as a domestic pathway, with further regulatory reforms planned to support innovation, including software and AI-based medical devices.
Devices certified under the former EU Medical Devices Directive (MDD) will not be recognised indefinitely. Under the planned arrangements, eligible legacy devices will be accepted in Great Britain in line with the applicable EU MDR transitional provisions, with the transition period currently ending on 31 December 2028. Applicable deadlines and eligibility depend on the device and its regulatory status.
These changes will require legislative implementation.
What does this mean for medical device manufacturers?
For manufacturers operating in both the EU and Great Britain, the decision offers several potential benefits:
- Greater regulatory predictability: Manufacturers can plan their market access strategies with increased confidence in the long-term recognition of EU MDR and IVDR certification.
- Reduced duplication: Qualifying CE-marked devices will not require a separate UKCA conformity assessment, potentially reducing regulatory costs and administrative work.
- Improved market continuity: Continued recognition helps manufacturers maintain access to the Great Britain market and reduces the risk of supply disruptions.
- More efficient market access planning: Manufacturers developing products for both markets can build their regulatory strategies around a more predictable framework.
With more than 90% of medical devices registered for use in Great Britain currently carrying a CE mark, the decision is particularly significant for maintaining access to established and innovative medical technologies.
UK regulatory obligations still apply
Importantly, indefinite recognition of CE marking does not remove all UK-specific regulatory responsibilities.
Manufacturers placing medical devices on the Great Britain market must continue to comply with applicable domestic requirements, including:
- Appointment of a UK Responsible Person, where required.
- Medical device registration with the MHRA.
- Applicable post-market surveillance and vigilance requirements.
- Ongoing compliance with relevant regulatory and safety obligations.
The MHRA will continue to oversee the safety and performance of medical devices available on the UK market, regardless of their conformity assessment route.
Access to the Great Britain market also depends on the EU certificate remaining valid, where certification by a notified body is required. If a notified body suspends or withdraws the certificate, access to both the EU and Great Britain markets is lost at the same time. Open findings in the EU technical documentation or quality management system therefore matter on both sides of the Channel.
Manufacturers should also distinguish between the regulatory frameworks applicable in Great Britain and Northern Ireland, where different market access arrangements apply.
What happens next?
Although the government’s policy direction is now confirmed, legislative changes are still needed to implement indefinite recognition. Indefinite recognition is a stated government intention, not yet law.
The government intends to introduce the necessary legislation before 30 June 2028, subject to parliamentary approval. Until the new legislation takes effect, the current transitional deadlines continue to apply.
Manufacturers should therefore continue to monitor MHRA guidance and the progress of the relevant legislation, particularly regarding transitional arrangements and any further changes to the UK regulatory framework.
The decision is part of a broader programme to modernise UK medical device regulations, including developments in post-market surveillance, conformity assessment and regulatory pathways for emerging technologies.
How can GBA Key2Compliance support you?
Navigating regulatory requirements across different markets can be challenging, particularly as the EU and UK frameworks continue to evolve.
At GBA Key2Compliance, we support medical device and IVD manufacturers with regulatory strategy, technical documentation, quality management systems and compliance with applicable requirements.
Whether you are preparing to enter the European or UK market, reviewing your regulatory strategy or ensuring continued compliance, our experts can help you identify the requirements relevant to your products.