In vitro diagnostic medical devices - Performance studies vigilance

Name: In vitro diagnostic medical devices - Performance studies vigilance
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: class-4,class-iv,clinical-investigation,data,diagnostics,events,forms,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,investigation,ivd,ivdmd,ivds,measures,medical-devices,notification,performance,procedures,reporting,safety,vigilance

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Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Last updated

June 24, 2024

Description

Procedure In vitro diagnostic medical devices - Vigilance of performance studies

Organization

National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷

Country / Region

France

License

Other (Non-Commercial)

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8 Main files

Formulaire d’accompagnement d’une déclaration d’un Fait Nouveau (FN) et/ou de Mesures Urgentes de Sécurité (MUS) concernant un essai clinique (RIPH1) portant sur un dispositif médical de diagnostic in vitro (DMDIV) (21/05/2021)

Updated on May 21, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/21/formulaire-fn-div.pdf
Permalink: https://data.openrid.co/en/datasets/r/63189c98-fac2-486f-80ac-e23093ac6e71
MIME Type: application/pdf

Created on: May 21, 2021
Modified on: May 21, 2021

Notification Form of a new event and/or Urgent Safety Measure (USM) concerning clinical investigations on in vitro medical device (IV-MD) (21/05/2021)

Updated on May 21, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/21/formulaire-fn-en-div.pdf
Permalink: https://data.openrid.co/en/datasets/r/a25b12f4-5ded-4066-bd0a-29518f394e14
MIME Type: application/pdf

Created on: May 21, 2021
Modified on: May 21, 2021

Format et contenu du rapport annuel de sécurité (RAS) d'une investigation clinique portant sur un DMDIV (21/05/2021)

Updated on May 21, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/21/surv-vig-doc110-v01-plan-ras.pdf
Permalink: https://data.openrid.co/en/datasets/r/3f543479-9274-4ff8-82cc-aa1f4413aef5
MIME Type: application/pdf

Created on: May 21, 2021
Modified on: May 21, 2021

Formulaire de déclaration de vigilance : déclaration initiale (21/05/2021)

Updated on May 21, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/21/surv-vig-for16-v01-form-decl-init-eig-dm-dmdiv.pdf
Permalink: https://data.openrid.co/en/datasets/r/a1e43bd0-3f7e-4596-9cba-66d3800f9596
MIME Type: application/pdf

Created on: May 21, 2021
Modified on: May 21, 2021

Vigilance report form : Initial report (21/05/2021)

Updated on May 21, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/21/surv-vig-for16-v01-form-decl-init-eig-dm-dmdiv-en.pdf
Permalink: https://data.openrid.co/en/datasets/r/f61ba43e-bfe9-4853-b025-256700ab38a1
MIME Type: application/pdf

Created on: May 21, 2021
Modified on: May 21, 2021

Formulaire de déclaration de vigilance : informations complémentaires/données de suivi (21/05/2021)

Updated on May 21, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/21/surv-vig-for17-v01-form-decl-compl-eig-dm-dmdiv.pdf
Permalink: https://data.openrid.co/en/datasets/r/b243033c-4f36-4269-b940-400d72d5b4dc
MIME Type: application/pdf

Created on: May 21, 2021
Modified on: May 21, 2021

See the 8 main files

In vitro diagnostic medical devices - Performance studies vigilance

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