In-House Medical Device Manufacturing within Great Britain

A new guidance document has been published regarding the in-house manufacturer of medical devices within Great Britain. This guidance is specifically relevant to healthcare institutions operating in England, Wales, and Scotland. It’s important to note that separate information is available for Northern Ireland.

What is In-House Manufacturer?

In-house manufacturer refers to the creation of medical devices within a healthcare establishment for use solely within that establishment. The new guidance outlines the minimum requirements these healthcare institutions must follow to ensure compliance with the Medical Devices Regulations 2002 (UK MDR 2002).

Key Points of the Guidance

• • Applicability: The guidance is only applicable to healthcare institutions in Great Britain.
  • Regulatory Compliance: Institutions must adhere to UK MDR 2002 regulations, particularly if devices are transferred between establishments or placed on the market.
  • Exemptions: Devices used within the same establishment, specialist R&D labs, and sterilization processes without ownership changes are exempt from these regulations.
  • Clinical Investigations: Any device manufactured for profit and used in clinical investigations must be notified to the MHRA.

Current Status

The guidance is currently under review, but healthcare institutions in Great Britain should continue to follow it until any updates are published.

Healthcare institutions must stay informed and compliant with these regulations to ensure the safe and effective use of in-house manufactured medical devices.

For more detailed information and updates, please refer to the official guidance document.

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