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...
Publications : Qualification
UE – MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED – November 2024
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...
UE – MDCG 2024-14 – Guidance on the implementation of the Master UDI-DI solution for contact lenses – October 2024
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...
Documentary Synthesis Artificial Intelligence
Area Publication or last update date Text Theme Scope nexialist synthesis EU 2016 Regulation (EU) 2016/679 on General Data Protective Regulation Data management Artificial intelligence Link EU 2018 European Commission : Questions and Answers: coordinated plan...
UE – MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – October 2024
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...
Asma Benidjer
With over five years of experience as an internal auditor and inspector in the financial sector, I have honed my regulatory skills and developed a particular proficiency in analyzing complex data. As a Doctor of Pharmacy and holder of a Master of Science in...
EU/European Commission: Artificial Intelligence Questions and Answers Update – August 2024
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,...
AI Act – what impact will it have on devices incorporating artificial intelligence systems?
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...
MDCG 2024-12 Oct 2024 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams. – Oct 2024
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)...
MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices – October 2024
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...