MHRA Seeks Feedback on Health Institution Exemption Policy

12th August 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a stakeholder survey to gather insights from health institutions in Great Britain regarding the health institution exemption (HIE) under the UK Medical Devices Regulations. This consultation aims to refine the policy to support the delivery of safe, effective, and innovative medical devices closer to patients' homes, aligning with the government's 10-Year Health Plan and Life Sciences Sector Plan. Key areas of focus include extending access to exempted devices beyond health institutions, strengthening post-market surveillance, and enabling reforms in healthcare delivery. The survey seeks to understand current practices and inform future consultations, guidance, or regulatory updates.

Link: Health Institution Exemption – Stakeholder Survey

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