This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...
Theme Clinical investigation report Target Audience Sponsor, competent authorities, Commission Products concerned MD Documents mentioned MDR (EU) 2017/745 – Art 77 MDCG 2021-1 Rev1 This guide explains the procedure for publishing clinical investigation reports...
Theme Highly individualised devices UDI Target Audience Manufacturers, notified bodies Products concerned Highly individualised MD : contact lenses Documents mentioned MDR (EU) 2017/745 - Annex VI part C MDCG 2018-1 This Guide details the procedures for...
Theme Regulatory status of ethylene oxide Target Audience Manufacturers, notified bodies Products concerned MD, IVD Documents mentioned RDM (EU) 2017/745 RDIV (EU) 2017/746 Regulation (EU) No 528/2012 on biocidal products This guide deals with the regulatory...
EU/European Commission: Artificial Intelligence Questions and Answers Update- August 2024 If summer and rest bring answers to your existential questions, this August the Commission brings you answers to all your questions about Artificial Intelligence. On August 1,...
Do you manufacture devices incorporating artificial intelligence systems and wonder how the newly published AI Act will impact you? Read the rest of this article 😉 The key message to remember: The MD and IVD Regulations continue to drive DM/IVDs incorporating AI! The...
Theme Conformity assessment bodies assessment with a view to designation as a notified body Target Audience Conformity assessment bodies, notified bodies, designating authorities, joint assessment teams Products concerned MD, IVD Documents mentioned IMDR (EU)...
Theme Qualification of IVD Target Audience Manufacturers, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 2(2) et 2(4) The purpose of this guidance document is to clarify which products fall within the scope of Regulation (EU) 2017/746 on...
Theme Clinical evaluation Target Audience Manufacturers, NB Products concerned Orphan medical devices Documents mentioned MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states These are guidelines for manufacturers and notified bodies...
Theme Re-assessment of notified bodies Target Audience Designating authority, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 article 40(10) MDCG 2022-13 This document is a template form to be used by the designating authority in the context of the...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
