Document equivalence arguments

If you rely on equivalent-device evidence, the rationale should address technical, biological, and clinical comparability. Differences must be identified and justified, not smoothed over.

Provide access to supporting data where required and avoid relying only on marketing claims or public descriptions. A strong equivalence argument needs enough evidence to let the expert judge whether the comparison is valid.

When equivalence is weak, the clinical evaluation may need additional evidence, a more limited claim, or a clear PMCF activity to address the residual uncertainty.