Government confirms indefinite CE recognition for medical devices

Last Updated on 22/10/2026 by Sarah Sarsby

The government has confirmed that it will continue to recognise CE marked medical devices and in vitro diagnostic devices (IVDs) in Great Britain on an indefinite basis. The decision follows the MHRA’s targeted consultation, to which the BHTA submitted a response supporting indefinite CE recognition.

For BHTA members manufacturing or supplying CE marked devices in Great Britain, the policy is intended to maintain market access, reduce duplicative regulatory processes, and support continuity of supply.

Implementation will require legislative changes. The government states that, subject to parliamentary approval, these will be made before 30 June 2028, the end of the earliest relevant transition period.

Continued market access for CE marked devices

The government intends to recognise indefinitely all CE marked medical devices certified under the EU Medical Devices Regulation (EU MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (EU IVDR), maintaining the relevant requirements in the UK Medical Devices Regulations 2002.

Lawrence Tallon, Chief Executive of the MHRA, said: “This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices. By continuing to recognise CE marked devices, we’re ensuring that patients across Great Britain maintain uninterrupted access to the medical technologies they depend on, from life-saving diagnostics to everyday treatments, while our wider device reforms will ensure our regulatory framework is ready for the innovative technologies of tomorrow, including AI-powered medical devices.”

In its consultation response, the BHTA strongly supported indefinite recognition of devices compliant with these EU regulations. It highlighted that continued access to the Great Britain market without additional approved body checks would reduce the risk of interruptions to medical device supply.

Alignment of transitional arrangements

Alongside indefinite recognition of devices certified under EU MDR and EU IVDR, the government intends to extend recognition of devices approved under the older EU Medical Devices Directive (EU MDD), aligning Great Britain’s recognition timelines with the EU timelines for transition to EU MDR. These devices would be accepted until the end of the EU transition period, currently 31 December 2028, while maintaining the requirements in regulation 19B of the UK Medical Devices Regulations 2002.

The BHTA supported this extension from the current Great Britain deadline of 30 June 2028 to minimise the risk of supply disruption. Its response highlighted the value of removing differences between EU and Great Britain transitional arrangements, particularly for SMEs and approved bodies.

The government also states that EU MDD-certified devices placed compliantly on the EU or Great Britain market before the end of the EU transitional arrangements will continue to be allowed on the Great Britain market, mirroring the EU approach.

Government will not proceed with separate reliance route

The government will not take forward the proposed approach that would have introduced a separate reliance route for devices with a higher risk classification in Great Britain than in the EU.

The BHTA opposed a two-tier approach in its response, raising concerns about classification disputes, additional requirements, and the potential costs, time, and complexity associated with a separate reliance route. The government’s decision is consistent with that position; its stated reason for not proceeding is to prevent unnecessary regulatory complexity.

Registration and safety obligations continue

Continued CE recognition retains domestic compliance requirements. Manufacturers, or their UK responsible person (UKRP), must continue to register devices placed on the Great Britain market with the MHRA. Manufacturers based outside the UK must appoint a UKRP.

Manufacturers must also comply with the strengthened post-market surveillance requirements that came into force in June 2025. The government’s response additionally identifies requirements for technical documentation and the certificate of conformity to be prepared and made available in English, and for compliance with enforcement notices.

UKCA and next steps

The UKCA marking route will remain available alongside CE recognition, and manufacturers of UKCA marked medical devices will continue to be able to supply their products in Great Britain. The government is also progressing reforms to the domestic route through a pre-market statutory instrument.

The CE recognition policy applies to Great Britain. Northern Ireland continues to apply certain EU regulations, and devices must bear the CE mark. The government states that continued recognition in Great Britain will support convergence across the UK.

The government has committed to continued engagement with patients, clinicians, and industry during implementation.

Members can read the government’s full response to the targeted consultation on indefinite recognition of CE marked medical devices.