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 Transitional provisions Target Audience Notified Bodies (NB) Products concerned IVD Regulatory reference IVDR (EU) 2017/746Article 110 Documents mentioned MDCG 2022-4MDCG 2022-6MDCG 2022-8MDCG 2019-10 rev.1MDCG 2022-12CAMD MDR/IVDR Transition subgroup : FAQ –...
With a master’s degree in IS Project Management and over 15 years of experience as an IT manager, I joined NEXIALIST as an ISR at the end of April 2022. I am very excited to have a job that I enjoy and that is of use to many people. I like to say that IT is the future...
Autodidact, with 25 years of experience in administration, I joined nexialist in April 2022 as a training coordinator. As the interface between learners, trainers, clients and funding bodies, I have to make sure that the wheels don't get stuck. New job, new challenge!...
With over 15 years of professional experience, mainly in SMEs of medical industry, I joined the nexialist team in June 2022. I successively contributed to Medical Devices' embedded software developments over their entire life cycle, then I took responsibilities of...
Graduated of a PhD in Vascular Physiology carried out in a research laboratory and in an electro-medical devices company, the aim was to demonstrate a new therapeutic indication of a class IIa device in the management of pain in diabetic patients with peripheral...
Theme Transition to the MDR and IVDR Target Audience Notified Bodies (NB), Manufacturers Products concerned MD & IVD Documents mentioned Regulation (EU) 2017/745 Regulation (EU) 2017/746 MDCG 2019-6 MDCG 2020-12 MDCG 2022-4 MDCG 2022-11 This document,...
Theme Designation of notified bodies Target Audience Notified Bodies, Designating Authorities (authorities responsible for notified bodies), Joint Assessment Teams Products concerned MD & IVD Documents mentioned Regulation (EU) 2017/745 Regulation (EU)...
Theme EUDAMED Target Audience Economic operators, Notified Bodies, Sponsors, Member States, European Commission Products concerned IVDs Documents mentioned Regulation (EU) 2017/746 Art. 113 (3) (f) This document presents in table form each article of Regulation...
Theme Compliance with MD Regulation Target Audience Manufacturers Products concerned MD Documents mentioned Regulation (EU) 2017/745 This position paper of the MDCG gives a numerical overview of the state of play regarding applications for conformity assessment...
