EUDAMED transition work plans for MedTech portfolios
Turning scattered public records and internal evidence into a transition queue is not the same as running a compliance check.
ClinicOps reconciles the portfolio evidence, separates legacy from MDR registration paths, surfaces unresolved inputs and orders what needs human review first, for manufacturers, authorised representatives and regulatory partners.
What the review can organise
Legacy identifier screening
For legacy devices, the EUDAMED DI carries the B- prefix and stands in place of a Basic UDI-DI. The prefix is a screening input: it does not by itself establish a device's regulatory or SS(C)P state, and ClinicOps never treats it as a compliance conclusion.
Designed for portfolio operations
The Transition Map earns its place when the problem is portfolio-scale reconciliation, not a single record: authorised representatives managing several manufacturers, manufacturers with class III or implantable transition workload, and consultancies that want a repeatable evidence layer.
Deliverable
A pilot returns intake diagnostics, role-aware portfolio segmentation, a priority work queue, an evidence-gap ledger and a human-reviewed action plan: a work plan, not an allegation that any manufacturer is non-compliant.
Related
Start small
Send a small portfolio export, or talk through the workflow first. ClinicOps shows what can be screened reproducibly and where manufacturer-controlled or other authoritative evidence is still needed.