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MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – April 2024

29 Apr 2024 | MDCG

Theme Investigator’s brochure Target Audience Sponsor of clinical investigations Products concerned MD Documents mentioned MDR (EU) 2017/745 : – article 70 – Annex XV Chapter II Section 2 ISO14155:2020 This guidance document is intended to assist sponsors of...

MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – Avril 2024

29 Apr 2024 | MDCG

Theme Safety reporting in performance studies Target Audience Sponsor of performance studies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 : article 76 In a context where the Eudamed electronic system for performance studies is not available, this...

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 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices – March 2024

18 Mar 2024 | All the News

Theme Clinical investigation plan (CIP) Target Audience Sponsor of clinical investigation Products concerned MD Documents mentioned RDM (EU) 2017/745 – article 70 – annex XV ISO14155:2020 This guide is intended to help sponsors draw up their...

MDCG 2024-2 : Procedures for the updates of the European Medical Device Nomenclature

13 Feb 2024 | MDCG

Theme European Medical Device Nomenclature (EMDN) Target Audience All the actors Products concerned MD, IVD Documents mentioned RDM (UE) 2017/745 – article 26 RDIV (UE) 2017/746 – article 23 This guide relates to the : revision of the European Medical Device...

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MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – April 2024

MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – Avril 2024

Delphine Dominé

MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices – March 2024

MDCG 2024-2 : Procedures for the updates of the European Medical Device Nomenclature

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MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – April 2024

MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 – Avril 2024

Delphine Dominé

MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices – March 2024

MDCG 2024-2 : Procedures for the updates of the European Medical Device Nomenclature

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