Publications : Medical devices

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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MDCG 2022-10 : Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Theme Clinical trials using diagnostic tests Target Audience Manufacturers and clinical trials sponsors Products concerned IVD & medicines Documents mentioned Regulation (EU) 2017/746 Regulation (EU) No 536/2014 Directive 98/79/EC   This guide provides...

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MDCG 2022-8 : Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC

Theme Transitional provisions Target Audience Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 IVDR – Article 110 Blue Guide MDCG 2019-5 MDCG 2021-13 rev.1   This...

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