4 docs tagged with "pms"

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. 10(8) / IVDR Art. 10(8) — manufacturers must maintain records that allow identification of all customers who received a device, enabling effective recalls and FSCAs. Importers and distributors have parallel obligations under MDR Art. 13(5) and Art. 14(5).

Regulatory basis - MDR Art. 83–86 / IVDR Art. 78–81. PMS is a proactive, systematic process that all manufacturers must implement. The depth and reporting frequency scale with device risk class.

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).