MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system – July 2021

7 Sep 2021 | All the News, MDCG

Theme UDI
Target Audience Manufacturers
Products concerned

MD & IVD
Documents mentioned

MDR (EU) 2017/745

IVDR (EU) 2017/746

MDCG 2018-1 v4 

MDCG 2018-3 Rev.1 

MDCG 2018-4 

MDCG 2018-5 

MDCG 2018-6 

MDCG 2018-7

IMDRF/UDI WG/N48 FINAL: 2019

 

This MDCG guide describes the steps to be taken when implementing an UDI system within a QMS according to the different stages of the life cycle of the devices concerned.