Artificial intelligence / machine-learning tool for post-market surveillance of in vitro diagnostic assays

Author:

Reniewicz Joanna,Suryaprakash Vinay,Kowalczyk Justyna,Blacha Anna,Kostello Greg,Tan Haiming,Wang Yan,Reineke Patrick,Manissero Davide

Publisher

Elsevier BV

Subject

Molecular Biology,General Medicine,Bioengineering,Biotechnology

Reference32 articles.

1. World Health Organization. Guidance for post-market survaillance and market surveillance of medical devices, including in vitro diagnostics, 〈https://www.who.int/publications/i/item/9789240015319〉; 2020 [accessed 5 June 2023].

2. European Parliament and the Council of the European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and Repealing Council Directives 90/385/EEC and 93/42/EEC, 〈https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745〉; 2017 [accessed 5 June 2023].

3. European Parliament and the Council of the European Union. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU, 〈https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN〉; 2017 [accessed 5 June 2023].

4. Akra B. The post market gambit: After EU MDR and IVDR: A systematic compliance framework for driving MedTech innovation: Independently published; 2022.

5. National Library of Medicine. Citations added to MEDLINE by fiscal year, 〈www.nlm.nih.gov/bsd/stats/cit_added.html〉; 2022 [accessed 5 June 2023].

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