On 21 May 2024, the UK Medicines and Healthcare products Regulation Agency (MHRA) issued a statement of policy intent describing a proposed framework under which the approval of medical devices by comparable international regulators could be recognised in Great Britain.

Current approach

Currently, medical devices must feature CE or UKCA marks to be sold in Great Britain. These marks demonstrate that the medical device has passed the relevant conformity assessment and is compliant with all applicable legislation in the EU, in the case of CE marks, or UK, in the case of UKCA marks. 

The MHRA confirmed that the general indefinite extension to use CE marks announced by UK government does not apply to medical devices meaning that CE marks on general medical devices will cease to be recognised in the UK after 30 June 2030. 

Proposed approach 

The MHRA has proposed a framework of international recognition whereby medical devices approved by “comparable regulator countries” (CRCs) can be sold in Great Britain. CRCs include Australia, Canada, the EU and USA.

Eligibility requirements for medical devices under the proposed framework include compliance with relevant legislation in the CRC, displaying English language labelling and packaging and featuring the name and address of the UK responsible person on the label. Some devices will be exempt from international recognition.

The proposed framework will provide a certificate of international recognition that will grant medical devices access to the Great Britain market, but will not provide a UKCA marking or certification.

Impact for manufacturers and patients

The purpose of the proposed new framework offers an alternative streamlined route for medical devices to be sold in Great Britain. It is intended that this will enhance patient access to medical devices to ensure that Great Britain remains an attractive market for MedTech innovators. The framework avoids duplication of assessments conducted by comparable regulators in the hope that resources can instead be focused on the development of innovative products. 

It will be interesting to see how the regime develops in practice, especially if a medical device suffers a safety issue after having been approved for use by a CRC outside of the control of the UK regulator.