Module 16 2024

18/10/2024

Ramifications of PSURs once available

• PSURs will become available for CAs:

• CAs will be able to compare this information with safety and performance data that can be obtained from other parts of EUDAMED, e.g. vigilance information, trend reports, incidents, etc.

• Furthermore, parts of EUDAMED will be available for Notified Bodies who will use this database for their surveillance assessments at manufacturers.

• Important for manufacturers to be aware that much more information about their devices is available and can be tracked.

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Ramifications of PSURs once available

• PSURs may require updates to the Summary of Safety and Clinical Performance (SSCP).

• Any SSCP updates arising from a new PSUR should be limited to the PSUR content.

• If SSCP modifications* go beyond PSUR disclosures, and are supported by other documents, e.g. CER, this is not a TD assessment, not a PSUR evaluation.

*Administrative amendments to an SSCP can be submitted with the updated PSUR.

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