Solution · Preparation

Evidence pack checklist.

Sending these items in one controlled batch reduces back-and-forth before comparison starts. For how a review uses them, see the review page.

What to gather

Approved source. The document or record that controls the change, with its version, date and location.
Change reference. The change-control or ECO number and the date it was approved.
EUDAMED evidence. An export or record view for the actor and device records in scope: SRN, Basic UDI-DI, UDI-DI, names and status.
Certificates. Certificate numbers, issuing notified body, and issue and expiry dates for the devices in scope.
SS(C)P. The master, the current revision and each maintained translation.
Labels and IFUs. The artwork or document revision for every language version in scope.
Declarations. The declaration of conformity and technical-documentation summary references.
Master data. A RIM, PLM or spreadsheet export for the same product family, with its export date.
Named owner. The role accountable for regulatory disposition, and who owns each surface.
Scope statement. Which surfaces are in and out, so later additions are visible rather than silently mixed in.

Send read-only copies, not live files. Name each file with its system, date and version.
Use one export date per surface, and note anything changed after that date.
Send structured data as CSV, XLSX or JSON, and documents as PDF or the native file.

Do not send patient-identifiable data, passwords or credentials, or confidential documents outside the declared scope.

Build a scope brief in your browser, then open it in your email client. Nothing is transmitted by the page.