Nuova legge europea per la diagnostica e standard ISO nella fase post-vendita dei dispositivi

Author:

Pradella Marco

Publisher

Edizioni Minerva Medica

Subject

Biochemistry (medical),Medical Laboratory Technology

Reference30 articles.

1. 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 [Internet]. Disponibile alla pagina: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505 [citato 21 ottobre 2020].

2. 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 [Internet]. Disponibile alla pagina: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20170505 [citato 21 ottobre 2020].

3. CAMD Implementation Taskforce. Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap [Internet]. Disponibile alla pagina: https://www.camd-europe.eu/wp-content/uploads/2018/05/NEWS_171107_MDR-IVDR_RoadMap_v1.3-1.pdf [citato 21 ottobre 2020].

4. Ministero della Salute. Nuova Legislazione europea per i dispositivi medici ed i dispositivi medico diagnostici in vitro (EU MDR / IVDR) [Internet]. Disponibile alla pagina: http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=4971&area=dispositivi-medici&menu=caratteristichegenerali [citato 21 ottobre 2020].

5. Sander M. MDI Europa. MDR and IVDR guidance updates. April 9, 2020 [Internet]. Disponibile alla pagina: https://mdi-europa.com/mdr-and-ivdr-guidance-updates/ [citato 21 ottobre 2020].

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