Theme Application/notification for performance studies Target Audience Sponsors, Competent authorities Products concerned IVD Regulatory reference IVDR (EU) 2017/746 Article 66 Article 69 Article 70(1) Documents mentioned MDCG 2022-12 As the EUDAMED database is...
Theme Legacy devices Target Audience Manufacturers, Notified bodies Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2020-3 MDCG 2021-25 This position paper concerns legacy medical devices, i.e. devices with an MDD or AIMDD...
Theme Hybrid audits Target Audience Notified bodies, Manufacturers Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2020-4 MDCG 2020-17 MDCG 2022-14 This MDCG document clarifies the definitions and...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
