2 docs tagged with "psur"

Regulatory basis - MDR Art. 85 / IVDR Art. 80. The PSUR is required for higher-risk device classes and must be submitted to the notified body via EUDAMED. MDCG 2022-21 provides detailed guidance on PSUR content and format.

MDR Annex III and IVDR Annex III define the post-market technical documentation requirements. Key documents are the PMS plan, PMS report / PSUR, and PMCF plan and evaluation report (MDR) or PMPF plan and evaluation report (IVDR).