Theme Clinical evaluation Target Audience Manufacturers, NB Products concerned Orphan medical devices Documents mentioned MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states These are guidelines for manufacturers and notified bodies...
Publications : Animal origin
MDCG 2024-9 – Preliminary re-assessment review template – IVDR (Regulation (EU) 2017/746) – May 2024
Theme Re-assessment of notified bodies Target Audience Designating authority, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 article 40(10) MDCG 2022-13 This document is a template form to be used by the designating authority in the context of the...
MDCG 2024-8 – Preliminary assessment review template – IVDR (Regulation (EU) 2017/746) – May 2024
Theme Assessment of notified bodies Target Audience Designating authority, NB Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 35 MDCG 2022-13 This guidance document is a form template to be used by the designating authority in the context of...
MDCG 2024-7 – Preliminary assessment review (PAR) form template (MDR) – May 2024.
Theme Assessment of notified bodies Target Audience Designating authority, NB Products concerned MD Documents mentioned MDR (EU) 2017/745 – article 39 MDCG 2022-13 This guidance document is a form template to be used by the designating authority as part of the...
MDCG 2024-6 – Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745) – May 2024
Theme Re-assessment of notified bodies Target Audience Designating authority, NB Products concerned MD Documents mentioned MDR (EU) 2017/745 article 46 MDCG 2022-13 This document provides a template form for use by designating Authorities (NAs) in the reassessment...
MDCG 2024-5 – Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices – April 2024
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
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
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
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 clinical...
MDCG 2024-2 : Procedures for the updates of the European Medical Device Nomenclature
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...