Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)

Name: Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: audits,diagnostics,guidances,in-vitro-diagnostics-regulation,ivdr,mdcg,mdr,mdsap,medical-device-single-audit-program,medical-devices,medical-devices-regulations,notified-bodies,regulations,reporting,surveillance

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Notified Bodies

Published

August 1, 2020

Last updated

August 1, 2020

Description

This document provides guidance for notified bodies on using MDSAP audit reports during surveillance audits under MDR/IVDR.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

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1 Main file

MDCG 2020-14

Updated on September 6, 2023

pdf

URL: https://health.ec.europa.eu/document/download/44dc96aa-e517-4af1-855b-f7fcb4b699c9_en?filename=md_2020-14-guidance-mdsap_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/8d450650-1862-4f31-9c63-349b2c1ced53
MIME Type: application/pdf

Created on: September 6, 2023
Modified on: September 6, 2023