QMS certificates

They cover the manufacturer's quality system rather than a single device. For higher-risk devices the notified body also issues certificates based on a full assessment of the technical documentation, while for many class IIa and IIb devices the technical documentation is assessed by sampling under the QMS certificate.

QMS certificates: QMS certificates are EU quality management system certificates (MDR and IVDR), EU quality assurance certificates (MDR) and EU production quality assurance certificates (IVDR) issued by notified bodies as a result of conformity assessments.

MDCG 2019-13 Rev.1, Section 3, Definitions (3.5)