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...
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...
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 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)...
