Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

Name: Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: appendixes,diagnostics,eu,european-union,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,mdcg,medical-devices,performance,regulations,reporting,safety

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

In Vitro Diagnostic Medical Devices (IVD)

Published

April 15, 2024

Last updated

April 15, 2024

Description

Document discusses safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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2 Main files

MDCG 2024-4

Updated on May 15, 2024

pdf

URL: https://health.ec.europa.eu/document/download/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/571300df-f99d-400c-a141-d6d2af54178f
MIME Type: application/pdf

Created on: May 15, 2024
Modified on: May 15, 2024

MDCG 2024-4 Appendix

Updated on July 9, 2024

xlsm

URL: https://health.ec.europa.eu/document/download/54cbbfd4-5808-4560-93ef-017f2a3b0f41_en?filename=mdcg_2024-4_appendix_en.xlsm
Permalink: https://data.openrid.co/en/datasets/r/ff617ac0-d156-44c6-83fc-aa12a3e7d1bf
MIME Type: application/vnd.ms-excel.sheet.macroenabled.12

Created on: July 9, 2024
Modified on: July 9, 2024