MHRA calls for stakeholder input on medical device standards
Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, and advisor to MedTech suppliers, reports on a new call for evidence from the Medicines and Healthcare products Regulatory Agency (MHRA) regarding designated standards for medical and in vitro diagnostic (IVD) devices.
The MHRA has launched a survey seeking feedback from stakeholders across the medical technology sector to inform its future approach to designating standards that support compliance with the UK Medical Devices Regulations 2002.
This initiative is part of a wider effort to develop a future regulatory framework that enhances patient and public safety, supports access to essential devices, and maintains the UK’s attractiveness to medical technology innovators. A key element of this strategy is greater alignment with international standards and best practices to ensure harmonisation and improved safety outcomes.
The call for evidence invites responses from all relevant stakeholders, including manufacturers, clinicians, and patient groups, to help prioritise which medical device standards should be designated. The MHRA emphasises that stakeholder input will be instrumental in ensuring that the designated standards are both practical and effective for those who use and rely on them.
The outcome of this consultation has the potential to significantly influence the future regulatory landscape for medical devices in the UK; and the MedTech sector should actively engage with it.
While the introduction of new or updated designated standards may require businesses to adapt existing products to meet revised requirements, greater alignment with international standards could ease access to global markets for UK manufacturers, enhancing competitiveness. A modernised regulatory framework may also better support innovation by reflecting the latest technologies and emerging healthcare solutions.
Interested stakeholders are invited to submit their feedback by 11:59pm on Tuesday, 30th September 2025 through the MHRA Designated Standards Prioritisation Survey.
The Author used AI in preparing this article, comments upon or questions about which can be addressed to [email protected].
Related
link
