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. 2024 Apr 12;62(9):e206-e208.
doi: 10.1515/cclm-2024-0389. Print 2024 Aug 27.

Facing the new IVD Regulation 2017/746: Contract Research Organizations (CROs), key partners of IVDs manufacturers for compliance

Sabrina Kali  1 , Chloé Puisney  1 , Marie-Laure Delalande  1 , Guillaume Franc  1 , Christiane Buisson  1 , Sébastien Barradeau  1
Affiliations

Facing the new IVD Regulation 2017/746: Contract Research Organizations (CROs), key partners of IVDs manufacturers for compliance

Sabrina Kali et al. Clin Chem Lab Med. .
No abstract available

Keywords: European regulation; IVDR compliance; analytical performance; clinical performance.

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References

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    1. Regulation – 2017/746 – EN – Medical Device Regulation – EUR-Lex [Internet]. [cited 2024 Mar 28] . Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj .
    1. Directive – 98/79 – EN – EUR-Lex [Internet]. [cited 2024 Mar 27] . Available from: https://eur-lex.europa.eu/eli/dir/1998/79/oj .
    1. Aronson, JK, Heneghan, C, Ferner, RE. Medical devices: definition, classification, and regulatory implications. Drug Saf 2020;43:83–93. https://doi.org/10.1007/s40264-019-00878-3 . - DOI
    1. Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux de diagnostic in vitro – Légifrance [Internet]. [cited 2024 Mar 28] . Available from: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000046113837 .

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