European Commission 17 June 2022, 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)

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European Union · · · Cited by 5 · 17-06-2022

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

20.6.2022

Official Journal of the European Union

L 164/7

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

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