Publications : MDCG

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 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...

One of the biggest changes brought about by the new regulations on medical devices and in vitro diagnostics, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) respectively, is the creation of a European medical device database (EUDAMED). EUDAMED will...

Theme COVID-19 - Audit Target Audience Notified Bodies, Manufacturers, Subcontractors Products concerned MD, IVD Documents mentioned MDCG 2020-4 : Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine...

Theme UDI - EUDAMED Target Audience Manufacturers Products concerned Spectacle lenses and ready readers Documents mentioned MDR (EU) 2017/745 Article 10(7) Chapter III : Article 27, Article 27(3), Article 29, Article 31 Annex VI   In this document, the Medical...