Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rule... (32022R0944)
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Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance)
- COMMISSION IMPLEMENTING REGULATION (EU) 2022/944
- of 17 June 2022
- laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of
- in vitro
- diagnostic medical devices
- (Text with EEA relevance)
- CHAPTER I
- CRITERIA FOR EU REFERENCE LABORATORIES
- Article 1
- Staff
- Article 2
- Equipment and reference materials
- Article 3
- International standards and best practices
- Article 4
- Administrative organisation and structure
- Article 5
- Confidentiality
- Article 6
- Public interest, independence and conflicts of interest
- Article 7
- Outsourcing of testing and access to equipment from other laboratories
- Article 8
- Accreditation
- Article 9
- Verification of compliance with criteria
- CHAPTER II
- TASKS OF THE EU REFERENCE LABORATORIES
- Article 10
- Contracts between the EU reference laboratories and requesting parties
- Article 11
- Requests from notified bodies regarding tasks referred to in Article 100(2), points (a) and (b), of Regulation (EU) 2017/746
- Article 12
- Verification of performance and compliance with common specifications or with other solutions chosen by the manufacturer
- Article 13
- Sample or batch testing
- Article 14
- Requests to perform tasks referred to in Article 100(2), points (c), (d), (f), (g) and (i), of Regulation (EU) 2017/746
- Article 15
- Setting up of a network of national reference laboratories
- Article 16
- Recommendations on suitable reference materials and reference measurement procedures of higher metrological order
- Article 17
- Sub-networks of EU reference laboratories
- Article 18
- Common rules of procedure
- CHAPTER III
- FINAL PROVISION
- Article 19
- Entry into force
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