◷ Roadmap
NB designation watch
NANDO designation churn × the certificates your watchlist holds — the full Art. 46 early-warning. New data source, bigger lift.
SRN and actor role, mandataire (AR) linkage, certificate status and issuing notified body — one search over the EUDAMED public record. Since 28 May 2026, EUDAMED use is mandatory (Decision (EU) 2025/2371) — operator verification isn't best practice anymore. It's expected.
The free search is the live product — no account needed.
100 credits a month, from the same wallet that pays for your exports, reveals and searches. No annual commitment, no euro subscription — turn it off whenever, and you keep the month you already paid for.
The verification, shown
Registered actor with a valid SRN and the right role · authorised representative appointed · certificate valid right now, and who issued it. The lookups the regulation expects — without the wait.
15 form fields, the timer re-fires on every pagination click — and certificate checks used to mean “request the cert PDF and phone the notified body.”
Measured: 15–18 s/query (openregulatory) · ~2 min for one operator page (Qualitiso, « Eudamed rame »)
Orthomed Implants GmbH
SRN DE-MF-000012345 · Manufacturer (MF)
Germany · Bayern
Built on EUDAMED public data · refreshed daily
Live today — this is the shipped company page, not a concept. ✓ Live
Submits straight to the live search — stopwatch it yourself.
No EUDAMED record found — here is what that can mean right now:
A zero-row answer without this context would be misleading evidence; we don't produce one.
The absence-explained empty state — the same caveat ships inside the dossier and every export.
The era changed on a dated decision
The mandatory era doesn't threaten auditors — it arms them. Three dates worth knowing:
28 May 2026
Mandatory use began
Actor, UDI/device, NB & certificates, market-surveillance modules — mandatory per Decision (EU) 2025/2371. Importer Art. 13 checks are now legally referenced lookups.
~28 Nov 2026
Legacy tail closes
Legacy-device registration deadline — the database fills up month by month, and until then a “no result” needs interpreting (see FAQ).
~May 2027
Certificate tail completes
NB certificate registration fully in; the vigilance module is forecast public ~2027 — not available today, and we say so.
33,000+ vs ~17,500
MDR applications filed vs certificates issued. (EC 18th NB survey)
13–18 months
typical NB review time — certificate timing is a standing client risk.
9–12 months
Art. 46 — the death clock. When a notified body loses designation, its certificates get 9–12 months to transfer. Every expiry is one an auditor should have seen coming.
Scroll on — three moments in your week where this pays for itself ↓
Workflow · 01 — Before the audit
A timestamped, source-referenced verification record per company — built for the supplier file your client's notified body will read.
Report ID MDA-VR-2026-0147
Generated 2026-07-02 14:32 UTC
Source EUDAMED public data
Query SRN = CH-MF-000045821
1 · Actor identity & roles — Art. 31
2 · Mandataire (AR) linkage — Art. 11
Manufacturer not established in the EU (Switzerland) → AR required: EuroRep B.V. NL-AR-000067890 ✓ linked
3 · Certificates — status history & issuing NB
history: Issued 2024-03-12 → Valid (no suspension events)
Issuing NB: GMED NB 0459
4 · Devices summary
14 registered devices · 11 MDR / 3 legacy · risk classes IIa–III
Scope & absence. This report reflects the EUDAMED public record at retrieval time. A “no result” can mean unregistered, non-compliant, or not-yet-migrated (legacy tail to ~Nov 2026) — it is stated, never silently omitted. Vigilance/FSCA data is not in EUDAMED's public scope until ~2027 and is not part of this report.
Spec preview of the dossier PDF · early members review the format before it ships · all names, SRNs and certificate numbers illustrative.
Provenance block. Retrieval timestamp (UTC), data-sync date, unique report ID — provenance you can defend when the supplier file is read.
Reproducible query. The exact search parameters are printed, so a second auditor can reproduce the lookup and reach the same record.
The AR check, demonstrated. Non-EU manufacturer → the mandataire linkage with its SRN; EU manufacturer → an explicit “not applicable (Art. 11)” line. The check is shown either way — never a dangling blank.
Status history, dated — NB named by NANDO number. The transition is the finding, not the snapshot: suspended / withdrawn / expired / reinstated events with dates, per EUDAMED's own status vocabulary, and the issuing NB as NB 0459, not just “GMED”.
Absence explained. A zero-row lookup states what absence can and cannot mean during the legacy-migration window. A blank report without this caveat is misleading evidence — so ours carries it.
See one before you buy anything.
Get the sample dossier (demo company) by email when the format is frozen.
Your watchlist · 19 companies
✓ Live todayG2-MDR-23-001177 · NB 9124 · event 2026-06-28 09:41 UTC · conformity alert sent
CH-MF-000045821 · event 2026-06-25 17:03 UTC
IT1-MDR-26-004402 · NB 0051 · event 2026-06-22 11:19 UTC
Conformity alerts — certificate-status changes (suspended / withdrawn / expired / reinstated), metered from your credit balance at the standard per-alert price, package or not. Not vigilance: FSCA data isn't public in EUDAMED until ~2027, and we don't pretend otherwise.
412 certificate-status changes recorded across EUDAMED in the last 7 days (illustrative)
Certificate-expiry horizon
✓ Live3
expire ≤ 6 mo
7
≤ 12 mo
12
≤ 18 mo
Sample counts — your real watchlist horizon is live in the product; open it from your feeds.
Workflow · 02 — Between audits
Follow as many companies as you need. Every change lands in your feed with a timestamp: certificate-status transitions, actor-record edits, new device registrations. Conformity alerts are included, so “did anything change since the last audit?” has an answer before you open the file — the recurring supplier-audit finding is the uncommunicated change.
The expiry horizon reads your whole watchlist forward: which certificates die in 6, 12, 18 months — the question the Art. 46 window and the NB-capacity crunch make your clients ask you.
Workflow · 03 — Writing the CER
MDCG 2021-12 frames the EMDN precisely as enabling the “identification of comparable products.” Walk the tree, filter by risk class, legislation and certificate status, and export the enumeration with its retrieval date and criteria — a dated search-protocol appendix, per MEDDEV 2.7/1 rev 4's documented search strategy.
EMDN C0104 · coronary stents (illustrative) · 128 devices
Export CSV / XLSXCoroFlex Pro · Class III
Médicorp SAS · MDRValid
StentMaster XR · Class III
Ortho-Dyn GmbH · MDRSuspended
Vitalia Flow C · Class IIb
Vitalia Medical S.r.l. · Legacy (MDD)Valid
| Device | Manufacturer | Class | Legislation | Certificate |
|---|---|---|---|---|
| CoroFlex Pro | Médicorp SAS | III | MDR | Valid |
| StentMaster XR | Ortho-Dyn GmbH | III | MDR | Suspended |
| Vitalia Flow C | Vitalia Medical S.r.l. | IIb | Legacy (MDD) | Valid |
Completeness statement (printed in every export): EUDAMED device registration is complete for post-May-2026 devices; legacy registration runs to ~Nov 2026. An enumeration cited without this caveat invites an NB finding — so the sentence ships inside the file.
The export enumerates the candidates; equivalence and appraisal (MDCG 2020-5) remain your clinical judgment. Comparator monitoring today = certificate-status changes on the manufacturers you watch; FSCA / vigilance arrives when the module goes public (~2027) — far roadmap, marked below.
In their words
“Request the cert PDF and phone the notified body.”
— the workaround auditors described for a decade, before the certificates module went mandatory. That sentence is why this product exists.
The honest catalogue
Every feature on this page carries its status. We never list a roadmap item as if it's live.
Fast company / device / certificate search
✓ Live todaySub-second lookups over the full EUDAMED public record — free tier included; the anti-18-seconds.
Watchlist — follow companies with change feeds
✓ Live capabilityFollowing is free and uncapped for everyone; the monitoring alerts it produces are metered from your credit balance. Your ASL, monitored daily.
Conformity alerts
✓ Live capabilityCertificate-status change alerts (suspended / withdrawn / expired / reinstated) — metered from your credit balance at the standard per-alert price, package or not. Not vigilance.
Exports — ~10 / yr included
✓ Live · includedCSV/XLSX, each stamped with retrieval date + criteria; the included quota is part of the package (pay-per-export for everyone else). One export = one search result set (FAQ).
EMDN tree filter (SOTA enumeration)
✓ Live todayBrowse any EMDN node; filter devices by class, legislation, certificate status.
MCP server (machine access)
✓ Live todayThe no-API pain, answered — for the technical minority who want it.
Audit-prep dossier (timestamped PDF verification report)
✓ Live · includedLive for members — a timestamped, print-ready verification report for any company you monitor.
Certificate-expiry horizon (6 / 12 / 18 months)
✓ Live · includedLive for members — your whole watchlist read forward at 6, 12 and 18 months.
NANDO designation churn × the certificates your watchlist holds — the full Art. 46 early-warning. New data source, bigger lift.
Waits on EUDAMED's vigilance module going public (~2027). Until then, nobody has this data — including us.
Pricing
€1–2k / day
what this cohort bills. A year of MD Atlas Audit is 1–2 billable hours.
€0.35–0.75 / lookup
what per-lookup competitors charge for UDI verification, plus monthly monitoring fees. A supplier list re-verified quarterly beats that inside the year.
100 credits / month
what the package rents for — from the same credit balance the rest of MD Atlas draws on.
€0
The anti-18-seconds, for everyone. Fast search is table stakes — it stays free.
Not included
100 credits / month
A recurring credit rent, not a euro subscription — no annual commitment, cancel whenever, and you keep the month you paid for.
Conformity alerts and watchlist monitoring are not bundled — they meter from the same credit balance at the standard price, package or not.
Get creditsCredits are one balance for everything: exports, contact reveals, searches and this package.
Already on MD Atlas Pro — €999/yr? These caps are already inside — Audit is caps, not feature absence. Pick the one that fits how much you verify.
Straight answers
You are here · /audit
Verify and monitor →
The data workflow: search, dossiers, watchlists, alerts, exports. You check on others.
Also wearing a consultant hat? · /qara
Get found and hired →
The visibility side: a verified, SEO-ranked professional home where manufacturers searching EUDAMED find you. Same wallet, opposite direction.
Verification in seconds today; the dossier and the expiry horizon rented by the month — with your name on the spec review.