MHRA Medical Devices Survey on In-House Manufacturing Exemption
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a new medical devices survey to collect feedback from health institutions on the in-house manufacturing exemption in the UK.
This exemption, introduced in 2021, allows devices manufactured and used within health institutions to bypass certain regulatory requirements. The latest MHRA medical devices survey aims to refine this exemption as part of the Medical Devices Regulatory Reform (MDRR) roadmap, ensuring patients receive safe, effective, and innovative devices.
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Key Focus Areas of the MHRA Consultation
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Expanding access so exempted devices may be used beyond health institutions.
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Strengthening post-market surveillance (PMS) requirements to improve device visibility and patient safety.
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Supporting the NHS shift from hospital to community care and from sickness treatment to prevention, with greater use of digital tools and early diagnosis.
Recent MDRR amendments already require manufacturers to proactively track the safety and performance of devices with a UKCA or CE mark placed on the UK market after June 16, 2025.
The MHRA stressed that stakeholder input is essential, as responses will shape future consultations, regulatory guidance, and medical device compliance updates in the UK.
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MHRA Survey May Change Exemption Rules—Stay Compliant With Operon Strategist.
Role of Operon Strategist
Operon Strategist plays a vital role in guiding medical device manufacturers through evolving regulations like the MHRA’s MDRR updates. We provide:
- Regulatory consulting for UKCA/CE marking.
- Guidance on post-market surveillance (PMS) compliance.
- Support for adapting to new exemption policies and documentation requirements.
- End-to-end consulting to help manufacturers and health institutions align with UK and international regulatory frameworks.
By staying ahead of regulatory reforms, Operon Strategist ensures manufacturers maintain compliance, avoid market delays, and bring safe, innovative devices to patients.
