Market Watch: the UK reliance pathway excludes the EU
A new GB route recognises US, Canadian and Australian approvals. Not European ones.
The signal
The UK medicines and devices regulator published draft amendments to the Medical Devices Regulations on 8 May 2026, establishing an International Reliance Pathway for Great Britain. An industry impact survey ran until 19 June 2026. Adoption is expected in December 2026, with the regulations in force from June 2027 and the reliance pathway itself taking effect in 2028.
Why it matters
The pathway recognises approvals from the United States, Canada and Australia. It does not include the European Union. Given that the large majority of devices on the GB market currently reach it through CE marking, that exclusion is the substance of the announcement rather than a detail of it. Continued recognition of CE marks is being handled separately, through a consultation that closed in April 2026, and the final scope of that recognition is still open.
The pathway runs through three routes by risk. The lowest-risk devices require only self-declaration and registration. Moderate and higher-risk categories require a Certificate of International Reliance from a UK approved body before registration.
The move
If you hold FDA, Health Canada or TGA approval, the UK becomes a sequenced entry point rather than a standalone assessment, from 2028. If your route into Great Britain runs through a CE mark, this pathway does not help you, and the separate question of indefinite CE recognition is the one that determines your access. Two different companies should draw opposite conclusions from the same announcement, which is the point worth taking from it.