Implement IVDR Compliant Quality Management System: Legacy IVD Devices

26 May 2025

Manufacturers of IVDD legacy devices must have implemented an IVDR-compliant quality management system (QMS) by today.

This is outlined in the IVDR Article 110(3c)(d): “no later than 26 May 2025, the manufacturer has put in place a quality management system in accordance with Article 10(8)“

Details

Date: 26 May 2025
Event Tags:Legacy Devices (MDD/AIMDD/IVDD), QMS

Other

Legislation: EU IVDR
Region: Europe

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