Annual reports & 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.
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.