Consultation measures support for fast track access to medical device imports

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking responses to three proposals intended to enable the automatic acceptance of CE marked medical devices without extra review.

CE marks confirm that a product complies with EU health, safety and environmental standards allowing it to be sold within the European Economic Area (EEA) and Turkey.

Since the advent of Brexit, the UK government has operated its own conformity assessments, notably UKCA.

However, transitional arrangements in 2021 and 2023 extended the period during which CE-marked goods could be placed on the domestic market. The ruling applies to Great Britain rather than the UK overall, as Northern Ireland operates separately.

A previous MHRA consultation last year highlighted widespread support from respondents for extending indefinitely the recognition of CE marked medical devices.

MHRA chief executive Lawrence Tallon said: “It is in the best of interests of British patients to ensure continued access to the latest medical devices approved in Europe. It is also in the best interests of the MedTech sector to reduce friction and costs of doing business.” 

The three proposals under consultation would if accepted:

• Extend transition arrangements for devices certified under the EU Medical Device Directive (MDD), to align with the Europe’s later transition to the EU Medical Device Regulation (EU MDR)
• Give indefinite recognition to devices that are EU MDR and EU IVDR (in vitro diagnostic regulation) compliant
• Introduce an ‘international reliance route’ to enable access for a restricted number of CE-marked devices from other regions after transitional arrangement cease in 2030.

Whereas recognition would involve acceptance of a decision by another, specifically EU regulator, reliance would acknowledge the assessment of a trusted foreign authority but leave the final decision with the British regulator.

In his foreword to the proposal document, parliamentary under-secretary for health, innovation and safety, Dr Zubir Ahmed the initiative would the speediest and safest access possible to medical devices.

“By ensuring rapid market access for new technologies, we can help treat patients more effectively, diagnose illness sooner, or prevent illness altogether,” he said.

“The proposed measures in this consultation will complement the wider reforms we are making to the regulatory framework for medical devices, particularly the international reliance scheme, which will enable swifter market access for certain devices that have already been approved in a comparable regulator country.”

An estimated 90% of medical devices now being used in Great Britain remain CE marked and the MHRA says indefinite recognition was needed to protect consistent long-term supply.

Head of regulatory affairs at NHS Scotland partner InnoScot Health, Elaine Gemmell called the consultation a “very necessary step” towards extending three-year-old arrangements and forging a closer regulatory relationship with the EU.

She added: “Having two separate regulatory regimes remains unsustainable … indefinite recognition reduces the complexities and fragmentation which have created uncertainty for those looking to innovate, invest, and thrive.”

Gemmell added that in addition to ensuring consistent supply for patients and professionals, there would be economic gains too.

“It would also [help] to ensure consistent supply of medical devices to patients and an enhanced strategic position for international growth ambitions. Our health and life sciences sectors must remain competitive in attracting innovative MedTech solutions.”

The deadline for consultation contributions is 10 April 2026. Click here for further details.

Pic: Matias Ramos