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Prepare EUDAMED and publication inputs

Collect the identifiers and public-facing device information needed for registration and publication.

UDI & Labelling

EUDAMED and publication inputs may include device identifiers, manufacturer details, authorized representative information, risk class, certificates, intended purpose, device description, and SSCP-related material where applicable.

Public-facing summaries should be consistent with the technical file but written for the intended audience. For patient-facing content, clarity matters as much as regulatory completeness.

If a notified body or authority requires a specific format, upload the correspondence or template so Complya and your expert can align the output to that expectation.

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Official references

This article is practical product guidance, not legal advice. Confirm regulatory deadlines and obligations against current official sources and your assigned expert.

European Commission — Medical Devices: New regulationsRegulation (EU) 2017/745 — Medical Device RegulationRegulation (EU) 2017/746 — In Vitro Diagnostic Medical Devices