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Evidence and covering

Why uploading evidence is separate from expert acceptance.

How the platform keeps records

Evidence is a document you provide. Covering is a judgement that the document actually supports a particular requirement. Providing the first does not create the second.

Where you meet it

When a requirement still shows "No evidence yet" after you uploaded something for it, and when a tagged document comes back as "Returned — action needed" with your expert's note.

The rule

A source can be uploaded, read, tagged and proposed as support before any expert has accepted that it covers the requirement. Coverage follows the current source, the current requirement and the current review — so it can also stop being true later, if the source is superseded or the requirement changes.

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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