Theme Re-assessment of notified bodies Target Audience Designating authority, NB Products concerned MD Documents mentioned MDR (EU) 2017/745 article 46 MDCG 2022-13 This document provides a template form for use by designating Authorities (NAs) in the reassessment...
Theme Investigator’s brochure Target Audience Sponsor of clinical investigations Products concerned MD Documents mentioned MDR (EU) 2017/745 : – article 70 – Annex XV Chapter II Section 2 ISO14155:2020 This guidance document is intended to assist sponsors of...
Theme Safety reporting in performance studies Target Audience Sponsor of performance studies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 : article 76 In a context where the Eudamed electronic system for performance studies is not available, this...
Theme European Medical Device Nomenclature (EMDN) Target Audience All the actors Products concerned MD, IVD Documents mentioned RDM (UE) 2017/745 – article 26 RDIV (UE) 2017/746 – article 23 This guide relates to the : revision of the European Medical Device...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
