Draft revised UK premarket regulation now publicly available

Continuing the UK Medicines and Healthcare products Regulatory Agency’s (MHRA’s) regulatory reform work, the Agency has now published details of the draft premarket statutory instrument, ‘The Medical Devices (Amendment) Regulations 2026’, as submitted to the WTO, alongside a supporting stakeholder survey.

The draft legislation introduces updated premarket requirements for medical devices and IVDs placed on the Great Britain (England, Scotland and Wales) market, including proposals relating to:

– Domestic UK routes to market
– The new International Reliance Pathway
– Technical documentation
– Classification
– Software change control
– UDI and registration requirements

The WTO notification is open for comment until 7 July 2026, while the MHRA stakeholder survey closes on 19 June 2026.

In the same week, at RAPS 2026, the MHRA announced updates on its consultation for indefinite CE Mark recognition and its own version of breakthrough device designation. The Agency has reportedly received over 1,000 responses to the consultation, with the expectation that the results will be the subject of a report in late July.

According to the MHRA representative, Nadine Neale, MHRA’s initial analysis has identified five important themes: Regulatory clarity; reduction of administrative burden; prevention of supply disruption; patient safety; and compliance concerns.

Though the final outcome of the consultation is yet to be decided, stakeholders are certainly expecting CE marks to be indefinitely recognized for GB market access, thus aligning compliance requirements across the whole of the UK.