On 11 May 2026, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a survey as part of its ongoing reform of pre-market medical device regulation in Great Britain. The survey forms part of a broader “call for evidence” linked to the draft Medical Devices (Amendment) Regulations 2026, which aim to modernise the existing regulatory framework and enhance patient safety.
Objective of the UK MDR consultation
The primary objective of the survey is to gather evidence on the practical implications of the proposed regulatory changes. Stakeholders are invited to provide feedback on expected costs, benefits, and implementation challenges, allowing the MHRA to better understand how the reforms may affect the medical device and in vitro diagnostic (IVD) sectors. The collected data should directly inform the Impact Assessment and support the finalisation and implementation of the new regulatory framework.
Reforms on updated pre-market requirements for medical devices and IVDs
The proposed reforms introduce updated pre-market requirements for medical devices and IVDs placed on the Great Britain market. These measures are designed to be patient-centred and proportionate, with the dual goal of improving safety while facilitating access to innovative technologies. The initiative builds on earlier consultations and regulatory developments, including the UK’s broader strategy to revise its post-Brexit medical device regime and align it more closely with international frameworks.
How to participate to the consultation
The MHRA is seeking input from a wide range of stakeholders, including:
- Medical device manufacturers and suppliers
- Healthcare professionals and providers
- Patients and patient organisations
- Trade associations and other interested parties
Respondents are encouraged to provide specific, evidence-based examples to ensure the assessment reflects real-world experiences across the sector.
The survey is open here until 19 June 2026, after which the MHRA will analyse responses in an aggregated and anonymised format. The relevant guidance can be found here.
Contact us here or at mdlaw@obelis.net for any questions on medical devices compliance!
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