Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)

Name: Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)
Creator: European Commission
License: https://creativecommons.org/licenses/by/4.0/
Keywords: compliance,diagnostics,guidances,in-vitro-diagnostic-devices,in-vitro-diagnostics,in-vitro-diagnostics-regulation,ivd,ivd-devices,ivdr,mdcg,mdr,medical-devices,medical-devices-regulations,person-responsible-for-regulatory-compliance,prrc,regulations,roles

Information

Type

Guidance

Regulated products

IVDMD, Medical Devices

Topics

Person Responsible For Regulatory Compliance (PRRC)

Published

December 1, 2023

Last updated

December 1, 2023

Description

This document provides guidance on the role of a 'person responsible for regulatory compliance' in medical device and in vitro diagnostic device regulations.

Organization

European Commission 🇪🇺

Country / Region

European Union

License

Creative Commons Attribution 4.0

Feedback

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1 Main file

MDCG 2019-7 - Rev.1

Updated on December 20, 2023

pdf

URL: https://health.ec.europa.eu/document/download/463b4f08-44a2-4018-9957-488bf386fc3a_en?filename=md_mdcg_2019_7_guidance_art15_mdr_ivdr_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/97a3e2bd-9ea3-49df-910d-be0739ce43bb
MIME Type: application/pdf

Created on: December 20, 2023
Modified on: December 20, 2023