Medical devices - Requesting authorization for a clinical investigation

Name: Medical devices - Requesting authorization for a clinical investigation
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: authorization,clinical-investigation,guidances,investigation,medical-devices,procedures,requests

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Last updated

August 7, 2024

Description

Procedure Medical devices - Requesting authorization for a clinical investigation

Organization

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

Country / Region

France

License

Other (Non-Commercial)

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20 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-dm-riph-1-v1-2-tqg-2.pdf
Permalink: https://data.openrid.co/en/datasets/r/353e0a2c-f69c-4983-9fb0-ea8ca7822492
MIME Type: application/pdf

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

Classification et process d’évaluation des investigations cliniques (DM) selon le règlement 2017/745 (RDM) et adaptations nationales (10/02/2022)

Updated on February 10, 2022

pdf

URL: https://ansm.sante.fr/uploads/2022/02/10/20220210-classification-et-process-devaluation-des-investigations-cliniques-dm-selon-le-reglement-2017-745-et-adaptations-nationales.pdf
Permalink: https://data.openrid.co/en/datasets/r/b4b141ae-6299-4421-a654-901ad991774f
MIME Type: application/pdf

Created on: February 10, 2022
Modified on: February 10, 2022

Avis aux promoteurs - Investigations cliniques de dispositifs médicaux relevant du règlement européen n°2017/745 (31/05/2021)

Updated on May 31, 2021

pdf

URL: https://ansm.sante.fr/uploads/2021/05/31/2021-05-28-aap-partie-i-dispo-generales-ic-dm-v1-2-tqg.pdf
Permalink: https://data.openrid.co/en/datasets/r/d60e4a97-62fe-470b-9324-304126bcb2d4
MIME Type: application/pdf

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

Modalités pratiques (04/02/2022)

Updated on February 4, 2022

pdf

URL: https://ansm.sante.fr/uploads/2022/02/04/20220204-modalites-pratiques.pdf
Permalink: https://data.openrid.co/en/datasets/r/8327a901-f57b-47f3-9775-9a94cf500dd3
MIME Type: application/pdf

Created on: February 4, 2022
Modified on: February 4, 2022

Annexe 1 : liste récapitulative des documents exigés par l’ANSM et les CPP (04/02/2022)

Updated on February 4, 2022

pdf

URL: https://ansm.sante.fr/uploads/2022/02/04/20220204-annexe-1-liste-recapitulative-des-documents-exiges-par-lansm-et-les-cpp.pdf
Permalink: https://data.openrid.co/en/datasets/r/8078257b-bde1-4cb2-87bc-af0f21140bb5
MIME Type: application/pdf

Created on: February 4, 2022
Modified on: February 4, 2022

Annexe 2 : modèle FAEC (02/03/2022)

Updated on March 2, 2022

docx

URL: https://ansm.sante.fr/uploads/2022/03/02/20220302-annexe-2-modele-faec.docx
Permalink: https://data.openrid.co/en/datasets/r/734bcde0-6b7c-426c-bd44-b3853d3684eb
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: March 2, 2022
Modified on: March 2, 2022

See the 20 main files