Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, flags a newly launched consultation by the UK’s medical device regulator.
The Medicines and Healthcare products Regulatory Agency (MHRA) is running a business and stakeholder impact survey on proposed changes to pre-market regulatory requirements for medical devices and in vitro diagnostic devices in Great Britain.
The proposals are set out in the draft Medical Devices (Amendment) Regulations 2026, which have also been published on the World Trade Organization notification portal so that overseas regulators are aware.
The draft Medical Devices (Amendment) Regulations 2026 seek, according to the MHRA, to bring forward patient-centred and proportionate regulatory requirements to prioritise patient safety and access to innovative medical technologies. These proposals build on earlier public consultation and engagement.
This survey seeks to gather evidence on the practical impacts for businesses of the proposed pre‑market changes, including likely costs, benefits, and implementation considerations.
The MHRA are seeking views from a range of stakeholders, including patients and patient representative organisations, healthcare professionals and healthcare providers, medical device manufacturers and suppliers, trade bodies and other interested organisations.
The deadline for completing the questionnaire is Friday 19 June 2026.
The Author used AI in preparing this article. Comments upon or questions about this article can be addressed to chris.whitehouse@whitehousecomms.com.
