Reporting of serious adverse events and device defects in performance studies initiated before May 26, 2022 with non-CE marked IVDs

Name: Reporting of serious adverse events and device defects in performance studies initiated before May 26, 2022 with non-CE marked IVDs
Creator: Ministry of Health (Italy)
License: https://creativecommons.org/licenses/by/3.0/
Keywords: adverse-events,defects,events,forms,in-vitro-diagnostic-medical-devices,ivdmd,ivds,medical-devices,performance,reporting

Information

Original link

Type

Miscellaneous

Regulated products

IVDMD, Medical Devices

Topics

Clinical Investigations And Performance Studies

Last updated

July 13, 2023

Description

Medical devices - Online forms and services

Organization

Ministry of Health (Italy) (MDS) 🇮🇹

Country / Region

Italy

License

Creative Commons Attribution 3.0

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3 Main files

Segnalazione di eventi avversi gravi e difetti dei dispositivi in studi delle prestazioni avviati prima del 26 maggio 2022 con IVD non marcati CE

Updated on July 13, 2023

html

URL: http://www.salute.gov.it/portale/ministro/p4_8_0_1.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb=SC&idSrv=IVD6&flag=P
Permalink: https://data.openrid.co/en/datasets/r/145eef1f-3378-487d-ae62-588db5f9187c
MIME Type: text/html

Created on: November 28, 2023
Modified on: July 13, 2023

8. Modulo SAE IT

Updated on November 28, 2023

xlsx

URL: https://www.salute.gov.it/imgs/C_17_pagineAree_5928_0_file.xlsx
Permalink: https://data.openrid.co/en/datasets/r/6a247fe1-bab2-4b91-9eac-ae3ea3334e2d
MIME Type: application/vnd.openxmlformats-officedocument.spreadsheetml.sheet

Created on: November 28, 2023
Modified on: November 28, 2023

8. SAE Form EN