Orientations réglementaires
Guidance on sufficient clinical evidence for legacy devices
Publié 1 avr. 2020
Référence
MDCG 2020-6
Source
MDCG
Thème
Clinical investigation and evaluation, performance studies and evaluation
Publié
1 avr. 2020
Langues
EN
© European Union — European Commission, DG SANTE. Reuse under CC BY 4.0.
Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746
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Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
Publié 1 nov. 2024
Clinical evaluation of orphan medical devices
Publié 1 juin 2024
Guidance on the Investigator’s Brochure content
Publié 1 avr. 2024