Medical devices - Clinical investigations vigilance

Name: Medical devices - Clinical investigations vigilance
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: applications,clinical-investigation,events,forms,guidances,investigation,measures,medical-devices,notification,procedures,regulations,research,safety,vigilance

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Last updated

June 24, 2024

Description

Procedure Medical devices - Vigilance of clinical investigations

Organization

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

Country / Region

France

License

Other (Non-Commercial)

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5 Main files

Avis aux promoteurs - Recherches impliquant la personne humaine mentionnées au 1° de l’article L. 1121-1 du code de la santé publique portant sur des dispositifs médicaux (RIPH1) (31/05/2021)

Updated on May 31, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/31/2021-05-28-aap-partie-ii-vigilance-dm-riph-1-v1-0-tqg-lf-31mai-3.pdf
Permalink: https://data.openrid.co/en/datasets/r/b9740f40-6249-4b79-b0f4-143552e4e683
MIME Type: application/pdf

Created on: May 31, 2021
Modified on: May 31, 2021

Formulaire d’accompagnement d’une déclaration d’un Fait Nouveau (FN) et/ou de Mesures Urgentes de Sécurité (MUS) concernant une RIPH1 portant sur un dispositif medical (DM) soumise avant le 26 mai 2021, date d’application du Règlement sur les dispositifs médicaux (31/05/2021)

Updated on May 31, 2021

docx

URL: https://ansm.sante.fr/uploads/2021/05/31/surv-vig-for15-v01-formulaire-fn-dm-riph-1-fr-vf-dajr.docx
Permalink: https://data.openrid.co/en/datasets/r/ffbd3a04-69eb-4a4d-b02f-caa4bf1ea2df
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 31, 2021
Modified on: May 31, 2021

Notification Form of a new event and/or Urgent Safety Measure (USM) concerning researches (RIPH1) on a medical device (MD) submitted before 26 May 2021, date of application of the Regulation on Medical Devices (31/05/2021)

Updated on May 31, 2021

docx

URL: https://ansm.sante.fr/uploads/2021/05/31/surv-vig-for15-a-v01-formulaire-fn-dm-riph1-en-vf-dajr.docx
Permalink: https://data.openrid.co/en/datasets/r/d66e291b-1387-4022-9ade-762ba6442f26
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: May 31, 2021
Modified on: May 31, 2021

Avis aux promoteurs - Investigations cliniques de dispositifs médicaux relevant du règlement européen n°2017/745 (19/11/2021)

Updated on November 19, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/11/19/2021-11-16-aap-partie-iv-vigilance-ic-dm-v2.pdf
Permalink: https://data.openrid.co/en/datasets/r/8a0df9b8-d445-4cd4-ba48-f7c2a151b3de
MIME Type: application/pdf

Created on: November 19, 2021
Modified on: November 19, 2021

Dispositifs médicaux – Vigilance des investigations cliniques

Updated on June 24, 2024

html

URL: https://ansm.sante.fr/vos-demarches/industriel/dispositifs-medicaux-vigilance-des-investigations-cliniques
Permalink: https://data.openrid.co/en/datasets/r/35bce760-3640-42d5-bf48-02a13de0a7f7
MIME Type: text/html

Created on: December 20, 2023
Modified on: June 24, 2024

Medical devices - Clinical investigations vigilance

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Regulated products

Last updated

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