The Medicines and Healthcare products Regulatory Agency has an Open call for evidence on proposed changes to pre-market regulatory requirements for medical devices and in vitro diagnostic devices in Great Britain.
The “Questionnaire on the Impacts of The Medical Devices (Amendment) Regulations 2026”, invites input from manufacturers, healthcare organisations, Approved Bodies, UK Responsible Persons, patients, and other stakeholders.
The proposed 2026 Regulations are intended to:
✔️ Strengthen patient safety
✔️ Support innovation in the medical device sector
✔️ Further align the Great Britain framework with international regulatory practices
✔️ Assess operational, economic, compliance, and equality impacts
MHRA prepared guidance to help navigate the questionnaire and understand the potential implications of the proposed changes.
This call for evidence closes on 19 June 2026!
Stakeholder feedback will play an important role in shaping the future regulatory framework and supporting the MHRA impact assessment process.
