Publications : Placing on the market

Delphine Dominé

 I’m a pharmacist specialized in Regulatory Affairs. During my university studies, I had the opportunity to acquire a lot of knowledge and skills, which reinforced my choice of a career in regulatory affairs in the healthcare field.  I joined nexialist in 2024 as a...

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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...

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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...

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