news & publications

Theme Clinical investigation plan (CIP)  Target Audience Sponsor of clinical investigation  Products concerned MD Documents mentioned RDM (EU) 2017/745   - article 70  - annex XV  ISO14155:2020  This guide is intended to help sponsors draw up their clinical...

This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...

Theme European Medical Device Nomenclature (EMDN)  Target Audience All the actors  Products concerned MD, IVD  Documents mentioned RDM (UE) 2017/745 – article 26  RDIV (UE) 2017/746 – article 23  This guide relates to the :  revision of the European Medical Device...

Theme Vigilance  Target Audience Manufacturers Products concerned Specific devices : cardiac ablation, coronary stents, cardiac implantable electronic devices, breast implants  Documents mentioned MDR (EU) 2017/745 – articles 87 et 88, 92  IVDR (EU) 2017/746 –...

Theme Clinical investigation exemption, demonstrating equivalence  Target Audience Manufacturers Products concerned Class III and implantable MD  Documents mentioned MDR (EU) 2017/745 – Article 61(4)-(6)  MDCG 2020-5   MDCG 2020-6   MDCG 2020-8  This MDCG guide aims...