EudaMed Monitor — Service 5

Automated CE certificate surveillance.
Priced by what it actually costs.

Monthly automated scanning of EUDAMED for counterfeit or unauthorised use of your certificates and UDI-DIs. Price follows compute load — your UDI-DI count, not your company size, determines your band.

Monthly scans  ·  12 per year  ·  MDR Article 83 periodic compliance  ·  Date-stamped PRRC report each cycle
Why UDI-DI volume determines price

The maths behind every band.

Every UDI-DI registered under your SRN is compared individually against every other UDI-DI in the EUDAMED database — currently approximately 2,000,000 entries — using 70%+ similarity matching. The comparison load scales directly with your portfolio size.

How your monthly scan load is calculated
Your UDI-DIs × 2,000,000 EUDAMED entries = comparisons per scan  ·  ×12 scans per year = annual processing volume
50
UDI-DIs
= 100M comparisons/scan  ·  1.2B/year
5,000
UDI-DIs
= 10B comparisons/scan  ·  120B/year
30,000
UDI-DIs
= 60B comparisons/scan  ·  720B/year
Pricing bands — monthly scanning

Six bands. One custom tier.

Select the band that matches your current UDI-DI count. Bands are based on the maximum comparisons your portfolio generates per monthly scan cycle. All bands include the same core deliverables.

Band 1 — Micro
Micro
1 – 100 UDI-DIs
€490
per year  ·  or €41/month
Monthly scan comparisonsup to 200M
Annual comparisonsup to 2.4B
Scans per year12
  • Monthly EUDAMED scan (1 SRN)
  • Date-stamped PRRC Compliance Report
  • CE certificate surveillance
  • Immediate alert on suspicious matches
  • Partner SRN whitelist (false positive control)
  • PDF report delivered to your account
Subscribe — €490/yr
Best for startups, single-product manufacturers, and companies building their EUDAMED compliance baseline.
Band 2 — Small
Small
101 – 500 UDI-DIs
€990
per year  ·  or €83/month
Monthly scan comparisonsup to 1B
Annual comparisonsup to 12B
Scans per year12
  • All Micro features
  • Up to 500 UDI-DIs monitored per scan
  • Monthly certificate expiry alert digest
  • Suspicious match summary per report
Subscribe — €990/yr
Suitable for small manufacturers with growing product portfolios across one or two product categories.
Most popular
Band 3 — Mid
Mid
501 – 2,000 UDI-DIs
€1,990
per year  ·  or €166/month
Monthly scan comparisonsup to 4B
Annual comparisonsup to 48B
Scans per year12
  • All Small features
  • Up to 2,000 UDI-DIs monitored
  • Dedicated scan queue allocation
  • Monthly PRRC compliance summary narrative
  • Certificate expiry dashboard access
Subscribe — €1,990/yr
The most common band for mid-size manufacturers with established product ranges across multiple EMDN categories.
Band 4 — Large
Large
2,001 – 10,000 UDI-DIs
€3,990
per year  ·  or €333/month
Monthly scan comparisonsup to 20B
Annual comparisonsup to 240B
Scans per year12
  • All Mid features
  • Up to 10,000 UDI-DIs monitored
  • Priority scan scheduling
  • Detailed match report with similarity scores
  • Dedicated support contact
Subscribe — €3,990/yr
Designed for large manufacturers and group entities with broad device portfolios spanning multiple SRNs.
Band 5 — Enterprise
Enterprise
10,001 – 30,000 UDI-DIs
€7,990
per year  ·  or €666/month
Monthly scan comparisonsup to 60B
Annual comparisonsup to 720B
Scans per year12
  • All Large features
  • Up to 30,000 UDI-DIs monitored
  • Annual PRRC compliance audit report
  • Executive summary per scan cycle
  • Multiple SRN coverage
  • API report delivery (JSON)
Subscribe — €7,990/yr
For enterprise manufacturers, Notified Bodies, and group purchasing organisations with large device registers.
Band 6 — Hyper
Hyper
30,001 – 50,000 UDI-DIs
€14,990
per year  ·  or €1,249/month
Monthly scan comparisonsup to 100B
Annual comparisonsup to 1.2T
Scans per year12
  • All Enterprise features
  • Up to 50,000 UDI-DIs monitored
  • Dedicated infrastructure allocation
  • SLA-backed delivery commitment
  • Quarterly executive compliance briefing
Subscribe — €14,990/yr
For the largest manufacturers and regulatory bodies in the EU medical device sector.
Band 7 — Custom
Custom — 50,001+ UDI-DIs
Bespoke
annual contract  ·  scoped individually
At 50,001+ UDI-DIs, the monthly scan generates over 100 billion comparisons. Infrastructure requirements, SLA guarantees, delivery architecture, and commercial terms are scoped individually. No published price — every engagement at this tier is unique.
Contact Sales →
Include your UDI-DI count, SRN count, and required SLA in your message

MDR Article 83 — personal liability of the PRRC

The Person Responsible for Regulatory Compliance (PRRC) is personally accountable under MDR Article 83 for post-market surveillance obligations. Monthly automated scanning with a date-stamped PRRC Compliance Report constitutes documented, auditable evidence that this obligation has been fulfilled — far exceeding what most manufacturers currently do. EudaMed Monitor is currently the only automated service providing this evidence from the public EUDAMED database.

Comparison table

All bands at a glance.

Every band delivers the same core service — monthly EUDAMED scan, PRRC Compliance Report, certificate surveillance, and alerting. The price reflects the actual compute load of your UDI-DI portfolio.

Band UDI-DI range Monthly comparisons Annual comparisons Annual price Monthly price
Micro1 – 100up to 200Mup to 2.4B€490€41
Small101 – 500up to 1Bup to 12B€990€83
Mid Popular501 – 2,000up to 4Bup to 48B€1,990€166
Large2,001 – 10,000up to 20Bup to 240B€3,990€333
Enterprise10,001 – 30,000up to 60Bup to 720B€7,990€666
Hyper30,001 – 50,000up to 100Bup to 1.2T€14,990€1,249
Custom50,001+100B+1.2T+Contact sales

All prices exclusive of VAT  ·  Invoiced in EUR  ·  Annual subscriptions

Subscriptions are annual. UDI-DI count is verified at onboarding against your EUDAMED SRN. If your portfolio grows into a higher band during the subscription year, the difference is invoiced on renewal. Bespoke multi-year pricing available on request — contact sales@eudamed.com.

Ready to protect your
CE certificates?

Register free to receive a sample PRRC Compliance Report showing exactly what your monthly scan delivers. No card required — upgrade to a paid band any time.

Register Free — Get Sample Report sales@eudamed.com

All prices exclusive of VAT  ·  Invoiced in EUR  ·  EirMed Ltd, Ireland

EudaMed Monitor is operated by EirMed Ltd (Ireland)  ·  Data sourced from the public EUDAMED database via search.eudamed.com  ·  Certified at eudamed.com
All plans subject to EirMed Ltd Terms of Service  ·  Prices exclusive of VAT  ·  © 2026 EirMed Ltd. All rights reserved.