11 Oct 2021 | All the News, MDCG, MDCG
Theme Classification Target Audience Manufacturers, Notified Bodies (NB) Products concerned MD Documents mentioned MDR (EU) 2017/745 Annex VIII This MDCG document is a real mine of information for interpreting the classification rules of the MD Regulation, which until...
7 Sep 2021 | All the News, MDCG
Theme Certificates Target Audience Notified bodies, distributors and importers Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 This guide is intended to assist NB in carrying out certification activities in accordance...
7 Sep 2021 | All the News, MDCG
Theme Expert panel consultation referred to in article 48(6) of Regulation (EU) 2017/746 Target Audience Notified bodies – Manufacturers Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Directive 98/79/EC This MDCG guide sets out criteria to...
7 Sep 2021 | All the News, MDCG
Theme COVID-19 – Performance evaluation Target Audience All stakeholders Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Directive 98/79/EC This document details the performance evaluation conditions for IVD’s intended for the detection or...
7 Sep 2021 | All the News, MDCG
Theme Eudamed2 – Clinical investigations Target Audience Competent authorities, clinical investigations sponsors Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-1 Rev.1. This guide provides Competent Authorities (CA) with the necessary...
