SS(C)P operations without losing the evidence trail
SS(C)P work is not just a document-upload task. It sits across manufacturer responsibility, Basic UDI-DI relationships, translations, notified-body validation context and downstream publication operations.
ClinicOps helps teams organise that evidence into a traceable work plan while preserving duty-holder context and unresolved questions.
Regulatory boundary
Under MDR Article 32, the manufacturer is the duty holder for drawing up the SSCP for applicable implantable and class III devices, subject to the Article 32 exclusions. ClinicOps does not replace that responsibility — the service is an evidence and operations layer around the work.
What ClinicOps can organise
EUDAMED operating model
MDCG 2026-4 describes a revised EUDAMED operating model in which the manufacturer uploads the SS(C)P master version and translations, while the notified body indicates the validated SS(C)P against the relevant Basic UDI-DI(s). This is a non-binding MDCG operating model tied to implementation of the new EUDAMED functionality and should be verified against current production behaviour before operational reliance.
Good fit
Manufacturers managing several SS(C)Ps and translations; authorised representatives that need portfolio visibility; regulatory teams preparing an evidence-led operational handoff; consultancies that want a repeatable reconciliation layer.
Deliverable
A typical engagement can return an evidence inventory, an unresolved-source register, Basic UDI-DI / SS(C)P relationship questions, a translation and handoff matrix, and prioritised human-review actions. No missing public field is treated as a standalone non-compliance finding.
Related
Start with one portfolio
Begin with one SS(C)P family or a small portfolio. ClinicOps will identify what can be reconciled, what remains unresolved and where authoritative evidence is needed.