Publications : Placing on the market

Alexis Kresser

After getting my STI2D graduation, I chose the path of a BTS SIO (Computer Service to Organizations) SISR option (Infrastructure system and network solution) in apprenticeship in order to develop my skills and acquire a first professional experience over a long...

read more

MDCG 2022-16 : Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – October 2022

Theme Authorised representatives’ obligations Target Audience Authorised representatives, Manufacturers and other economic operators Products concerned MD/IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-7MDCG 2019-13MDCG...

read more

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 –...

read more

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...

read more

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...

read more

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...

read more

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...

read more

Archives

Contact us

Le Forum Bat B
515 Avenue de La Tramontane
13600 La Ciotat
FRANCE

+33 (0)4 42 01 60 29
Write us