Theme UDI Target Audience Manufacturer Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 Annex VI IVDR (EU) 2017/746 IMDRF/UDI WG/N48 FINAL: 2019 MDCG 2019-11 This document is intended to provide interpretations on how certain principles and...
Theme UDI Target Audience Manufacturer Products concerned MD (contact lenses, spectacles frames, spectacles lenses and ready readers) Documents mentioned MDR (EU) 2017/745 Chapter III Annex VI MDCG 2020-18 This position paper is intended to provide further...
Theme Clinical investigations Target Audience Sponsors Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-1 Rev.1 This guide lists all the useful documentation for clinical investigation requests in accordance with the MDR (EU) 2017/745 and...
Theme COVID-19 Tests Target Audience Manufacturers, Authorised representatives Products concerned IVD Documents mentioned IVDR (EU) 2017/746 MEDDEV 2.12-1 This document is intended for manufacturers and authorised representatives of in vitro diagnostic medical...
Theme Clinical investigation Target Audience Sponsors (recital 49) Products concerned MD Documents mentioned MDR (EU) 2017/746 Chapter VI Directive 90/385/EEC Directive 93/42/EEC ISO 14155 :2020 Aimed primarily at sponsors of clinical investigations, MDCG...
Theme Harmonised standard, conformity assessment Target Audience Manufacturers, Subcontractors, Notified Bodies Products concerned MD and IVDMD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 Directive 90/385/EEC Directive 93/42/EEC Directive 98/79/EC...
Theme Transitional provisions – Conformity Assessment - EURL Target Audience Manufacturers, Notified Bodies Products concerned Class D IVD Documents mentioned IVDR (EU) 2017/746 This guide in the form of questions and answers provides indications on how to...
Theme Custom-Made, Adaptable and Patient-Matched medical devices Target Audience Manufacturers Products concerned MD Documents mentioned MDR (EU) 2017/745 Article 2(3), 16(1) Annex XIII IMDRF/PMD WG/N49 FINAL:2018 This document aims to answer questions...
Theme Performance evaluation - COVID-19 Target Audience Manufacturers Products concerned IVD Documents mentioned Directive 98/79/EC Annexes I & III IMDRF/GRRP WG/N47 FINAL:2018 This new MDCG guide focuses on the state of the art of COVID-19 rapid antibody...
Theme EUDAMED Target Audience Economic Operators, Notified Bodies, Sponsors, Member-State, European Commission Products concerned MD - IVD Documents mentioned MDR (EU) 2017/745 – Article 123(3) (d) Directive 93/42/EEC Directive 90/385/EEC This 31-page guide...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
