Reporting of serious adverse events and device defects in performance studies with IVDs

Name: Reporting of serious adverse events and device defects in performance studies with 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

May 8, 2024

Description

Medical devices - Online forms and services

Organization

Ministry of Health (Italy) (MDS) 🇮🇹

Country / Region

Italy

License

Creative Commons Attribution 3.0

Feedback

Suggest an improvement to this page

2 Main files

Segnalazione di eventi avversi gravi e difetti dei dispositivi in studi delle prestazioni con IVD

Updated on May 8, 2024

html

URL: http://www.salute.gov.it/portale/ministro/p4_8_0_1.jsp?lingua=italiano&label=servizionline&idMat=DM&idAmb=SC&idSrv=IVD5&flag=P
Permalink: https://data.openrid.co/en/datasets/r/9c34cf5a-be33-4fdf-a41d-4ae276c45e5b
MIME Type: text/html

Created on: November 28, 2023
Modified on: May 8, 2024

Performance Study Summary Safety Reporting Form

Updated on May 28, 2024

xlsm

URL: https://www.salute.gov.it/imgs/C_17_pagineAree_5928_0_file.xlsm
Permalink: https://data.openrid.co/en/datasets/r/9ad9bfa6-5818-449f-b4db-6c07a46c7de1
MIME Type: application/vnd.ms-excel.sheet.macroenabled.12

Created on: May 28, 2024
Modified on: May 28, 2024