24 Nov 2020 | MDCG
Theme Clinical investigation Target audience Sponsors (Manufacturer, Legal Representative or Contact Person) Products concerned Investigational MD Regulatory references MDR (EU) 2017/745 Article 80(2) This document defines the modalities for reporting Serious...
24 Nov 2020 | MDCG
Theme Ventilators – Covid-19 Target Audience Manufacturers, Notified Bodies Product concerned MD : Ventilators and their accessories Regulatory reference MDR (EU) 2017/745 Article 59 MDD 93/42/EEC Article 11(13) Documents mentioned EN ISO/IEC 80601-2-12:2011 +...
24 Nov 2020 | MDCG
Theme Post-market Clinical Follow-up Target audience Manufacturers, Notified bodies Products concerned MD (including Legacy Devices)* Regulatory references MDR (EU) 2017/745 Article 61 Annex XIV – Part B EN – This guide provides a detailed evaluation...
24 Nov 2020 | MDCG
Theme Post-Market Clinical Follow-up Target audience Manufacturers, Notified bodies Product concerned MD (including Legacy Devices)* Regulatory references MDR (EU) 2017/745 Article 61 Annex XIV – Part B EN – This guide provides a detailed template...
24 Nov 2020 | MDCG
Theme Clinical Evaluation – clinical evidence Target audience Manufacturer, Notified bodies Product concerned MD CE-marked under Directives Regulatory reference MDR (EU) 2017/745 Article 61 Annex XIV – Part A Documents mentioned MEDDEV 2.7/1 rev. 4 (2016) : Clinical...
