Module 18 2021

06/02/2021

ISO 20916:2019 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice: https://www.iso.org/standard/69455.html

IVDR- and MDR Factsheets from the European Commission https://ec.europa.eu/health/md_newregulations/publications_en

MedTech Europe, the overall association of the European medical technology industry (members of the diagnostic industry and the medical technology industry): http://www.medtecheurope.org/

European Medicines Agency http://www.ema.europa.eu/ema/

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN

References Part II

The Organisation for Professionals in Regulatory Affairs

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