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.