Facing the new IVD Regulation 2017/746: Contract Research Organizations (CROs), key partners of IVDs manufacturers for compliance
Author:
Affiliation:
1. Cerba Xpert, ZA les Epineaux , Frépillon , France
Publisher
Walter de Gruyter GmbH
Link
https://www.degruyter.com/document/doi/10.1515/cclm-2024-0389/pdf
Reference9 articles.
1. Rohr, UP, Binder, C, Dieterle, T, Giusti, F, Messina, CGM, Toerien, E, et al.. The value of in vitro diagnostic testing in medical practice: a status report. PLoS One 2016;11:e0149856. https://doi.org/10.1371/journal.pone.0149856.
2. 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.
3. Directive – 98/79 – EN – EUR-Lex [Internet]. [cited 2024 Mar 27]. Available from: https://eur-lex.europa.eu/eli/dir/1998/79/oj.
4. 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.
5. Ordonnance n° 2022-1086 du 29 juillet 2022 portant adaptation du droit français au règlement
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