Quality Management SystemQuality Management SystemQuality Management SystemQuality Management System
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Unique Device Identifier
December 8, 2023
EU Authorized Representative
December 8, 2023

Quality Management System

December 8, 2023

All manufacturers must implement a quality management system (QMS).

 

Generally, manufacturers implement to EN ISO 13485. It is a standard that was developed specifically for medical devices and has been harmonized in Europe, i.e., it generally meets the QMS requirements of the IVDR.  

 

  • Class A non-sterile manufacturers: QMS may be less robust than higher-risk devices but must at least meet the minimum requirements under IVDR Article 10(8). Further, the QMS does not have to be audited by a third party.
  • All other manufacturers: implement a QMS and undergo review by a Notified Body.
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