news & publications

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...

  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...

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...