Theme Clinical investigation
Target Audience Sponsors (recital 49)
Products concerned MD
Documents mentioned MDR (EU) 2017/746

Chapter VI

Directive 90/385/EEC

Directive 93/42/EEC

ISO 14155 :2020

 

Aimed primarily at sponsors of clinical investigations, MDCG 2021-6 provides clarifications in the form of questions and answers on the conditions for carrying out these different types of investigations under Regulation (EU) 2017/745.