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...
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...
My career has been built in high-stakes environments: 17 years of managing complex projects in high-end events, followed by 13 years devoted to the commercial and marketing development of medical devices. Two demanding worlds, but the same logic of value creation:...
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...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
