22 Mar 2021 | MDCG
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...
22 Mar 2021 | MDCG
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...
22 Mar 2021 | MDCG
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...
![New MDCG 2021-1 Guide : administrative practices and technical solutions to be followed in the absence of EUDAMED]()
5 Mar 2021 | MDCG
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...
![New MDCG 2021-1 Guide : administrative practices and technical solutions to be followed in the absence of EUDAMED]()
29 Jan 2021 | Regulation
The normative environment for the biological evaluation of medical devices has changed significantly in recent years. The 2018 version of ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process has...
