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

9 Nov 2022 | All the News, MDCG, MDCG

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...

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

22 Sep 2022 | All the News

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 –...
Christian Bordelet

Christian Bordelet

15 Sep 2022 | The team

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...
Cécile Reynès

Cécile Reynès

8 Sep 2022 | All the News, The team

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...