Clinical trials: Pilot phase procedure for the creation and processing of applications for medical devices

Name: Clinical trials: Pilot phase procedure for the creation and processing of applications for medical devices
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: adverse-events,applications,clinical-investigation,clinical-trials,committees,declarations,events,guide,investigation,medical-devices,pilot,procedures,reporting,research

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Original link

Type

Miscellaneous

Regulated products

IVDMD, Medical Devices

Published

February 17, 2021

Last updated

May 25, 2021

Description

Clinical trials: Pilot phase procedure for the creation and processing of applications for medical devices

Organization

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

Country / Region

France

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12 Main files

Guide pratique d'information pour les demandeurs - Investigations cliniques de dispositifs médicaux deposées dans le cadre de la phase pilote à l’ANSM et au CPP dispositif médical de diagnostic in vitro (DMDIV) - Recherche 1 (24/07/2019)

Updated on July 24, 2019

pdf

URL: https://ansm.sante.fr/uploads/2021/02/17/aec-doc025-v01-guide-pp-dm-juillet-2019-v2.pdf
Permalink: https://data.openrid.co/en/datasets/r/3d3b490f-b28f-4ed8-abdd-e10f4d445496
MIME Type: application/pdf

Created on: July 24, 2019
Modified on: July 24, 2019

Practical information guide for applicants medival device clinical investigations submitted to the ANSM and ethics committee within the pilot phase (24/07/2019)

Updated on July 24, 2019

pdf

URL: https://ansm.sante.fr/uploads/2021/02/17/aec-doc025-v01-guide-pp-dm-juillet-2019-en.pdf
Permalink: https://data.openrid.co/en/datasets/r/92eb77b5-6932-41ad-9dae-72b04f98fba3
MIME Type: application/pdf

Created on: July 24, 2019
Modified on: July 24, 2019

RIPH- Courrier demande d'autorisation initiale portant sur un dispositif médical (DM) ou dispositif médical de diagnostic in vitro (DMDIV) - Recherche 1 (30/08/2019)

Updated on August 30, 2019

docx

URL: https://ansm.sante.fr/uploads/2021/02/17/aec-for066-aecdmdmdiv-dde-cour-v05.docx
Permalink: https://data.openrid.co/en/datasets/r/2823524d-bf4d-4816-ba18-e32d5cc47235
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 30, 2019
Modified on: August 30, 2019

Télécharger le Guide de la phase pilote (01/12/2020)

Updated on December 1, 2020

pdf

URL: https://ansm.sante.fr/uploads/2021/02/17/20201201-guide-phase-pilote-dm-invasif.pdf
Permalink: https://data.openrid.co/en/datasets/r/96a27e8f-939c-4f10-8ce3-3c385d29506e
MIME Type: application/pdf

Created on: December 1, 2020
Modified on: December 1, 2020

Phase pilote relative à la déclaration des événements indésirables graves survenus au cours des recherches biomédicales portant sur un dispositif médical (30/07/2013)

Updated on July 30, 2013

pdf

URL: https://ansm.sante.fr/uploads/2021/02/17/phase-pilote-relative-a-la-declaration-des-evenements-indesirables-graves-survenus-au-cours-des-recherches-biomedicales-portant-sur-un-dispositif-medical-30072013.pdf
Permalink: https://data.openrid.co/en/datasets/r/9658e332-5148-4644-a187-ddea2e44c00b
MIME Type: application/pdf

Created on: July 30, 2013
Modified on: July 30, 2013

Pilot phase relative to the declaration of serious adverse events occurring during biomedical research concerning a medical device (30/07/2013)

Updated on July 30, 2013

pdf

URL: https://ansm.sante.fr/uploads/2021/02/17/pilot-phase-relative-to-the-declaration-of-serious-adverse-events-occurring-during-biomedical-research-concerning-a-medical-device-30072013.pdf
Permalink: https://data.openrid.co/en/datasets/r/516b617a-04fc-4aac-a652-d7dc0e931692
MIME Type: application/pdf

Created on: July 30, 2013
Modified on: July 30, 2013

See the 12 main files

Clinical trials: Pilot phase procedure for the creation and processing of applications for medical devices

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