Theme Classification Target audience Manufacturers, Notified Bodies (NB) Products concerned IVD Regulatory references IVDR (EU) 2017/746 Annex VIII This MDCG document is a real mine of information for interpreting the classification rules of the IVD...
Theme EUDAMED Target audience Manufacturers, Importers, Authorised representatives, Persons as referred to in Article 22 (systems and procedure packs) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 30(1) Article 31(2)...
Theme Surveillance audits MDR / MDSAP Target audience Notified Bodies (NB) Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Recital 32 Article 10(9) IVDR (EU) 2017/746 Recital 31 Article 10(8) Documents mentioned MDSAP Audit...
Theme Clinical evaluation Target audience Notified Bodies Products concerned MD Regulatory references MDR (EU) 2017/745 Article 61 Annex VII section 4.5.5 This document presents a template of a clinical evaluation assessment report (CEAR). This is the report used by...
Theme Specific additional procedures Target audience Notified Bodies, Manufacturers Products concerned · Devices containing a substance which may be considered a medicinal product and which has action ancillary to that of the device · Devices...
Theme Designation and monitoring of Notified Bodies (NB) Target audience Authority responsible for Notified Bodies Products concerned MD, AIMD Documents mentioned Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No...
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...
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 +...
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...
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 for...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
