Requesting a waiver for a medical device without CE marking

Name: Requesting a waiver for a medical device without CE marking
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: class-3,class-iii,guidances,medical-devices,procedures,prostheses,requests,waiver

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Last updated

August 8, 2024

Description

Procedure Requesting a waiver for a medical device without CE marking

Organization

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

Country / Region

France

License

Other (Non-Commercial)

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12 Main files

Liste des éléments de système prothétique pour implants dentaires CINY de la société GLOBAL D dont la mise à disposition est autorisée à titre dérogatoire pour des reprises partielles (13/02/2023)

Updated on February 13, 2023

pdf

URL: https://ansm.sante.fr/uploads/2023/02/13/20230213-derogation-ce-global-d.pdf
Permalink: https://data.openrid.co/en/datasets/r/6570ed9f-b4af-44d9-84b3-8088b1dc4f73
MIME Type: application/pdf

Created on: February 13, 2023
Modified on: February 13, 2023

Liste des éléments de systèmes prothétiques concernés par la dérogation (26/05/2023)

Updated on May 26, 2023

xlsx

URL: https://ansm.sante.fr/uploads/2023/05/26/20230526-dm-derogation-ce-liste-des-produits-a-deroger-clinic-2023-pj-de-la-derogation.xlsx
Permalink: https://data.openrid.co/en/datasets/r/021974b4-36fe-47e6-a7d5-e451f12668e9
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 26, 2023
Modified on: May 26, 2023

Liste des références Hexacolor nécessaires aux reprises (26/05/2023)

Updated on May 26, 2023

xlsx

URL: https://ansm.sante.fr/uploads/2023/05/26/20230526-dm-derogation-ce-liste-des-produits-a-deroger-hexacolor-2023-pj-de-la-derogation.xlsx
Permalink: https://data.openrid.co/en/datasets/r/89508e0c-34d5-4647-87d9-54669c2844fd
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: May 26, 2023
Modified on: May 26, 2023

Annexe 1 : liste des inserts du Groupe Lepine bénéficiant d'une dérogation annuelle 2024/2025 (06/03/2024)

Updated on March 6, 2024

xlsx

URL: https://ansm.sante.fr/uploads/2024/03/06/annexe-derogannuelle-2400179.xlsx
Permalink: https://data.openrid.co/en/datasets/r/04bf8c05-cb80-45e3-80a3-c83b2f3d082c
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: March 6, 2024
Modified on: March 6, 2024

Liste des têtes fémorales Groupe Lepine bénéficiant d’une dérogation annuelle 2024/2025 (27/02/2024)

Updated on February 27, 2024

xls

URL: https://ansm.sante.fr/uploads/2024/02/27/20240227-derogation-dm-lepine.xls
Permalink: https://data.openrid.co/en/datasets/r/17fcc14c-f6af-41ca-9ee4-ef4303419451
MIME Type: application/vnd.ms-excel

Created on: February 27, 2024
Modified on: February 27, 2024

Liste des têtes fémorales en acier ionxydable avec un cône 9X11et des cônes de rattrapge pour prothèse de hanche de la société BIOTECHNI dont la mise à disposition est autorisée à titre dérogatoire pour des reprises partielles (29/01/2024)

Updated on January 29, 2024

xls

URL: https://ansm.sante.fr/uploads/2024/01/29/20240129-derogation-dm-biotechni.xls
Permalink: https://data.openrid.co/en/datasets/r/ade783b6-1f05-41a5-ad0c-a1b38dfb7e47
MIME Type: application/vnd.ms-excel

Created on: January 29, 2024
Modified on: January 29, 2024

See the 12 main files

Requesting a waiver for a medical device without CE marking

Information

Type

Regulated products

Last updated

Description

Tags

Organization

Country / Region

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Feedback

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