Devices and diagnostics

Medical device safety and performance evidence

IMDRF sets out general safety and performance principles across device and IVD lifecycles. Evidence depends on intended purpose, device and market; one generic list cannot cover every product.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: N47 supports convergence; check local requirements and applicable standards.

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Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

State intended purpose, user and use environment.
Link device risks to controls and evidence.
Identify relevant clinical or performance evidence.
Connect claims and instructions to traceability and follow-up.

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Medical device safety and performance evidence

Prepare your evidence before a decision

Continue to practice