Theme Authorised representatives’ obligations Target Audience Authorised representatives, Manufacturers and other economic operators Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-7MDCG 2019-13MDCG...
Theme Transition to the MDR and IVDR Target Audience Notified Bodies (NB), Manufacturers Products concerned MD & IVD Documents mentioned Regulation (EU) 2017/745 Regulation (EU) 2017/746 MDCG 2019-6 MDCG 2020-12 MDCG 2022-4 MDCG 2022-11 This document,...
Theme Designation of notified bodies Target Audience Notified Bodies, Designating Authorities (authorities responsible for notified bodies), Joint Assessment Teams Products concerned MD & IVD Documents mentioned Regulation (EU) 2017/745 Regulation (EU)...
Theme EUDAMED Target Audience Economic operators, Notified Bodies, Sponsors, Member States, European Commission Products concerned IVDs Documents mentioned Regulation (EU) 2017/746 Art. 113 (3) (f) This document presents in table form each article of Regulation...
Theme Compliance with MD Regulation Target Audience Manufacturers Products concerned MD Documents mentioned Regulation (EU) 2017/745 This position paper of the MDCG gives a numerical overview of the state of play regarding applications for conformity assessment...
Theme Clinical trials using diagnostic tests Target Audience Manufacturers and clinical trials sponsors Products concerned IVD & medicines Documents mentioned Regulation (EU) 2017/746 Regulation (EU) No 536/2014 Directive 98/79/EC This guide provides...
Theme Summary of safety and performance (SSP) Target Audience Manufacturer Products concerned Class C and D IVD Documents mentioned Regulation (EU) 2017/746 This guidance presents the model of the summary of safety and performance (SSP). This one must be established...
Theme Transitional provisions Target Audience Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 IVDR – Article 110 Blue Guide MDCG 2019-5 MDCG 2021-13 rev.1 This...
Theme UDI Target Audience Manufacturers, systems and procedure packs producers, kit producers Products concerned MD, IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 UDI FAQ MDCG 2018-1 MDCG 2018-6 MDCG 2021-19 MDCG 2021-27 COMMISSION IMPLEMENTING...
Theme Significant change under the transitional provisions Target Audience Manufacturer Products concerned IVD : legacy devices Documents mentioned Regulation (EU) 2017/746 Directive 98/79/EC MDCG 2020-3 Regulation (EC) 1272/2008 Regulation (EC) No 1907/2006 Q&A...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
