Delphine Dominé

Delphine Dominé

19 Mar 2024 | The team

 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...

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

2 Jan 2024 | MDCG, MDCG

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...