The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories).
Article 100(4) of Regulation (EU) 2017/746 specifies the requirements that must be met by EU reference labs. In order to assure adherence to these standards, the Commission will establish specific regulations.
This document specifies the regulations for:
The #IVDR Regulation (EU) 2017/746 establishes guidelines for European Union reference labs (EU reference #laboratories).
- Personnel Requirements
- Equipment and Reference Materials
- International standards and best methods
- Organization and structure of administrative
- Privacy
- Public interest, independence, and potential conflicts of interest
- Contracting out tests and using equipment from other labs
- Accreditation
- Compliance with criterion verification
- Obligations and duties
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