EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
IVDR - Identification + UDI + Registration + EUDAMED (Ch III)

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) IVDR-Art.29_30: Summary of safety and performance + European database (Articles 29-30)

What does IVDR-Art.29_30 require?

Article 29 requires the manufacturer to draw up, for Class C and Class D devices (other than performance-study devices), a summary of safety and performance (SSP) accessible through EUDAMED. The SSP is written in plain language and made publicly available; it is part of the technical documentation. Article 30 establishes EUDAMED, the European database on medical devices (operated by the Commission), interconnecting the UDI / registration / NB+certificates / clinical-performance studies / vigilance / market surveillance modules.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

EU Medical Devices Regulation (MDR 2017/745) · 1 control

  • MDR-Art.32_33 Summary of Safety and Clinical Performance + EUDAMED (Articles 32-33)

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Other controls in IVDR - Identification + UDI + Registration + EUDAMED (Ch III)

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MCP endpointAll EU In Vitro Diagnostic Medical Devices Regulation (IVDR) controls