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Summary of Safety and Clinical Performance

In the Post-Market Clinical Follow-up (PMCF) phase under MDR, the Summary of Safety and Clinical Performance (SSCP) serves as a vital tool in ensuring the ongoing safety and efficacy of class IIb and III medical devices. It centralizes safety and performance data, fostering transparency by being publicly available in Eudamed, and necessitates bi-annual updates aligned with the device’s technical documentation. This critical document facilitates regulatory compliance, informed decision-making by healthcare professionals, and periodic evaluations by notified bodies
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