Theme Artificial intelligence Target Audience Manufacturers, notified bodies, competent authorities Products concerned MD and IVD integrating artificial intelligence systems (AIS) In June 2025, the MDCG published a guide concerning the interconnection between the MD...
Theme Performance studies Target Audience Sponsors of performance studies, manufacturers Products concerned IVD The MDCG published a question and answers document in June 2025 regarding performance studies of in vitro diagnostic (IVD) medical devices conducted under...
Theme Making available medical device software applications on the market Target Audience Suppliers of medical device software application platforms Products concerned MD and IVD software applications In June 2025, the MDCG published a guide describing the roles and...
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 EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published an excel table showing the revision history of all EMDN codes added, deleted or modified in 2024.
Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published a document presenting the results of the analysis of submissions made during the annual procedure for revising the European...
Theme EMDN Target Audience Competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published a model form for submitting proposals under the ad hoc updating procedure for the European Medical Device Nomenclature (EMDN). As a...
On the eve of its 40th anniversary, the Liability for defective product Directive is being renewed to adapt to technological innovations, combat legal inconsistencies and ensure legislative consistency within the EU. Published in the Official Journal of the European...
The Swiss Ordinance on in vitro diagnostic medical devices (IvDO) was amended by Federal Council Decision RO 2024 741 of 20 November 2024 (link in French), which came into force on 1 January 2025. So what are the changes brought about by this revision at the start of...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
