The European Commission published on December 14 in the Official Journal of the EU the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use for medical devices...
Theme Obligations of persons referred to in Article 16 Target Audience Importers and distributors Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 This guide presents a series of questions and answers about the obligations of...
Theme Interpretation of the transitional provisions for DM certified under the Directives Target Audience Manufacturers, Notified Bodies Products concerned MD certified under the directives (IVD excluded) Documents mentioned MDR (EU) 2017/745 MDR – Article 120 Blue...
In order to ensure a continuous supply of in vitro diagnostic medical devices, the European Commission proposes to extend the periods initially foreseen in the Regulation concerning the transitional provisions. Please note that this proposal does not aim to change the...
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...
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...
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 be...
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...
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...
Theme UDI Target Audience Manufacturers Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2018-1 v4 MDCG 2018-3 Rev.1 MDCG 2018-4 MDCG 2018-5 MDCG 2018-6 MDCG 2018-7 IMDRF/UDI WG/N48 FINAL: 2019 This MDCG guide...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
