Publications : Clinical trials

MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence

Theme Clinical investigation exemption, demonstrating equivalence  Target Audience Manufacturers Products concerned Class III and implantable MD  Documents mentioned MDR (EU) 2017/745 – Article 61(4)-(6)  MDCG 2020-5   MDCG 2020-6   MDCG 2020-8  This MDCG guide aims...

read more

Souha Dachraoui

I worked as a physiotherapist for two years, after that I worked as a medical representative for a pharmaceutical laboratory. Then I decided to broad my skills and get a degree in Engineering and Ergonomics of Physical Activity before completing my academic career...

read more

Laetitia Frank

After more than 20 years’ experience in medical devices and in vitro diagnostic medical devices fields, I joined nexialist team in November 2022. With an academic background in biomaterials, I had the opportunity to work in different environments : Research...

read more

MDCG 2023-2 List of standard fees – January 2023

Theme List of standard fees Target Audience Notified bodies Products concerned MD, IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-6Recommendation 2003/361/EC Regulations (EU) 2017/745 and 2017/746 require Notified Bodies to...

read more


Contact us

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

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