Publications : Qualification

Summaries of MDCG documents

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...

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MDCG 2022-15 : Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD – Septembre 2022

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 –...

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Christian Bordelet

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...

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Céline Corrado

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!...

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Eric Millot

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...

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Cécile Reynès

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...

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MDCG 2022-12 : Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) – Juillet 2022

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...

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