EUDAMED transition work plans for MedTech portfolios
Moving a portfolio from fragmented public records and internal evidence to an actionable transition queue is not the same as running a compliance check.
ClinicOps helps manufacturers, authorised representatives and regulatory partners reconcile portfolio evidence, separate legacy and MDR registration paths, surface unresolved inputs and decide what deserves human review first.
What the review can organise
Legacy identifier screening
For EUDAMED legacy-device identification, the EUDAMED DI uses the B- prefix and stands in place of a Basic UDI-DI for the legacy registration model. Identifier structure alone does not establish the complete regulatory or SS(C)P state of a device. ClinicOps therefore uses identifier structure as a screening input, not as a standalone compliance conclusion.
Designed for portfolio operations
The Transition Map is especially useful when the operational problem is portfolio-scale reconciliation rather than a single-record question. Best-fit users include authorised representatives managing multiple manufacturers, manufacturers with class III or implantable transition workload, and regulatory consultancies that want a repeatable evidence and prioritisation layer.
Deliverable
A typical pilot produces intake diagnostics, role-aware portfolio segmentation, a priority work queue, an evidence-gap ledger, and a human-reviewed action plan. The deliverable is a work plan, not an allegation that a manufacturer is non-compliant.
Related
Start small
Send a small portfolio export or discuss the workflow first. ClinicOps will identify what can be screened reproducibly and where manufacturer-controlled or other authoritative evidence is still required.