The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a call for evidence to collect feedback from stakeholders on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices.
This initiative forms part of MHRA’s efforts to deliver a future regulatory framework. This framework aims at prioritising patient and public safety as well as ensuring timely access to medical technologies. At the same time sustaining the UK’s position as an attractive market for innovation is always a goal.
In line with these objectives, the MHRA seeks to improve alignment with international standards and best practices.
Scope and input requested
Stakeholders are invited to provide input on the prioritisation of standards to be designated under the UK Medical Device Regulations 2002.
The feedback received will play a central role in ensuring that designated standards are practical, effective, and beneficial across the medical technology sector. Manufacturers, industry professionals, and other interested parties are encouraged to share their views and experiences on the standards most relevant to their activities.
Timeline and survey questions
The consultation will remain open until 30 September 2025. Participants can download the survey questions in advance and complete the official questionnaire via the MHRA website.
For any questions regarding the UK compliance of your medical devices and IVDs, contact MDlaw Team here or at mdlaw@obelis.net.
References
Medicines and Healthcare products Regulatory Agency (2025). Designated standards prioritisation. Retrieved on 08/09/2025
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