Class III and implantable MDR transition, organised into a work plan
Class III and implantable devices carry the heaviest MDR transition workload, and the pressure rarely comes from a single record. It comes from reconciling legacy and MDR registration paths, certificate timing, and SS(C)P duty across a whole portfolio at once.
ClinicOps maps that portfolio for manufacturers and authorised representatives: which devices sit on a legacy path, which on an MDR path, where the timing questions are, and what needs human review first.
The workload is not one certificate. It is a portfolio moving at different speeds.
Teams hold public EUDAMED records, notified-body certificate dates, internal transition evidence and SS(C)P material that were never designed to be read together. The hard part is not another data point. It is knowing which devices are approaching a timing constraint, which identifiers still need reconciling, and which SS(C)P obligations sit with the manufacturer as duty holder.
Class III & Implantable Transition Map
For a supplied or publicly screenable portfolio, the map covers manufacturer, authorised representative and actor-role context; legacy versus MDR registration path; a certificate and transition timing queue where reliable evidence is supplied; identifier and Basic UDI-DI reconciliation questions, including B-prefixed legacy-style EUDAMED DI signals; SS(C)P duty and workflow questions for applicable devices; explicit unresolved evidence gaps; and a human-reviewed action plan.
The deliverable is a work plan, not an allegation that a manufacturer is non-compliant.
SS(C)P duty boundary
Under MDR Article 32, the manufacturer is the duty holder for drawing up the summary of safety and clinical performance (SS(C)P) for applicable implantable and class III devices, subject to the Article 32 exclusions. ClinicOps does not assume that duty or replace the manufacturer's RA/QA responsibility: it organises the evidence and surfaces the questions around the duty, and the regulatory decision stays with the responsible party.
Legacy identifier screening
A B-prefixed EUDAMED DI marks the legacy registration model. ClinicOps uses identifier structure as a screening input, not a standalone compliance conclusion.
Best fit
Manufacturers with class III or implantable transition workload; authorised representatives managing several such portfolios; regulatory consultancies that want a repeatable evidence and prioritisation layer.
Related
Start with one portfolio, not a platform project
Send a small class III or implantable portfolio export, or talk through the workflow first.
What a small pilot needs and produces
Start with: a small portfolio export or agreed record set, plus the identifiers, certificate timing and target-market context already available. Missing fields stay as explicit evidence gaps; nothing is guessed.
Output: a prioritised work plan with evidence gaps and human-reviewed next steps, grounded in the supplied or reachable evidence. Final judgement stays with the responsible regulatory team.