Under the UK Medical Devices Regulations 2002 (as amended), which broadly mirror the EU Medical Device Regulation (MDR), a hospital or healthcare institution can manufacture medical devices for their own use, provided certain conditions are met. This is often referred to as “in-house manufacture” or a “health institution exemption.”
Key Requirements and Conditions
To qualify for this exemption, the following conditions typically apply:
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No Commercial Distribution:
- The device must not be marketed or sold to other institutions or third parties. It must be used exclusively within the same legal entity (e.g., NHS Trust).
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Quality Management System (QMS):
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A suitable QMS must be in place, covering the manufacture, testing, and ongoing risk management of the device.
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This system should comply with principles outlined in ISO 13485, even if full certification is not required.
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Clinical Oversight and Documentation:
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Full documentation of design, manufacturing, performance, and safety must be available.
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Risk assessments and usability evaluations are expected.
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Devices must meet essential safety and performance requirements, just like commercially produced equivalents.
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Post-Market Surveillance:
- Even though the device is not placed on the market, vigilance obligations still apply (e.g., reporting adverse incidents to the MHRA).
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Transparency with the MHRA:
- The Medicines and Healthcare products Regulatory Agency (MHRA) may require notification or audits of such in-house production practices.
Practical Examples
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A hospital laboratory developing a custom diagnostic tool.
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A biomedical engineering team fabricating patient-specific orthopedic implants.
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A radiology department creating a software algorithm for internal diagnostic use.
** Conclusion**
Hospitals can legally manufacture and use their own medical devices within the UK if:
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The device is for internal use only,
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There is an appropriate quality management system,
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The hospital complies with safety and documentation obligations.
This exemption enables innovation and customization of medical devices while maintaining patient safety and regulatory oversight. If you need the exact regulatory text or guidance from MHRA, I can retrieve it or help interpret specific clauses.