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Regulatory requirements for in-house IVDs
Version 2.2, September 2018
Laboratory networks are a group of laboratory organisations that operate under a single quality management system (QMS). A laboratory network is defined in Regulation 1.3 of the MD Regulations.
The QMS must be managed centrally, and applied uniformly across all work locations which manufacture and use the in-house IVD. However, some local work instructions may be necessary due to location-specific requirements.
As a minimum requirement, the following elements of the QMS must be managed centrally:
- management review
- internal quality audits
- corrective and preventive action
- changes to the quality system documentation for key elements.
Laboratory organisations with appropriate NATA corporate accreditation can be considered a laboratory network, and can manufacture and distribute in-house IVDs within their network.