Clinical investigations with medical devices

Name: Clinical investigations with medical devices
Creator: Spanish Agency for Medicines and Medical Devices
Keywords: clinical-investigation,eu,european-union,investigation,medical-devices,regulations,requirements,updates

Information

Type

Miscellaneous

Regulated products

Medical Devices

Published

May 2, 2019

Last updated

June 10, 2024

Description

Updated: 30 January 2023 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter "Regulation") sets out the general requirements in relation to clinical investigations involving medical devices in Chapter VI and the...

Organization

Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸

Country / Region

Spain

License

Other (Public Domain)

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2 Main files

Formulario de datos básicos de la solicitud de autorización de investigaciones clínicas con productos sanitarios

Updated on November 16, 2023

pdf

URL: https://www.aemps.gob.es/investigacionClinica/productosSanitarios/docs/ANEXO_C-Formulario_de_datos_basicos_de_la_solicitud.pdf
Permalink: https://data.openrid.co/en/datasets/r/11ffbe8f-92d2-4c90-a8d4-6a76edb7bb1d
MIME Type: application/pdf

Created on: November 16, 2023
Modified on: November 16, 2023

Formulario de datos básicos de la solicitud de autorización de investigaciones clínicas con productos sanitarios.

Investigaciones clínicas con productos sanitarios

Updated on June 10, 2024

html

URL: https://www.aemps.gob.es/productos-sanitarios/investigacionclinica-productossanitarios/
Permalink: https://data.openrid.co/en/datasets/r/f15ebb31-ce43-4956-8dc6-3c73c83331fd
MIME Type: text/html

Created on: May 2, 2019
Modified on: June 10, 2024