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...
Theme Clinical evaluation, demonstrating equivalence Target Audience Manufacturers, notified bodies Products concerned Products without an intended purpose listed in Annex XVI of MDR Documents mentioned MDR (EU) 2017/745 - Annex XIV, Annex XVI Implementing...
Theme Substantial modification of performance study Target Audience Sponsors, Competent authorities Products concerned IVD Regulatory reference IVDR (EU) 2017/746 Article 66(1) Article 70(1) Article 71 Documents mentioned MDCG 2022-19 As the EUDAMED database is...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
