AI reads your existing docs (PDFs, Excel, Word) and extracts UDI data automatically with confidence scores.
Schema-validated EUDAMED XML generated automatically. Your RA team never touches XML code.
UDI-DI per variant, hierarchical packaging levels (unit, case, pallet), clinical sizes variants.
Same data model feeds your eTD, QMS, labels, and EUDAMED. No duplication, no drift.
Who approved, when, which version. Complete compliance trail on every change & submission.
CertHub tracks EUDAMED XSD changes for you. No manual rework when schemas evolve.
Automatic Data Reading: AI extracts product & UDI data from PDFs, Excel, Word, scanned forms and PLM/ALM systems.
Confidence Scores: Every extracted field comes with a confidence score and source reference for full transparency.
Review & Approve: Field-level validation with MDR guidance, you stay in control.
No Re-Entry: 80% less manual effort compared to typing data into EUDAMED directly.
Validated XML Output: CertHub generates EUDAMED XSD-validated, versioned XML automatically.
Real-Time Validation: Invalid XML cannot be downloaded, errors caught before export.
No IT Dependency: Your RA team never touches XML code, just upload the file to EUDAMED.
Step-by-Step Upload Checklist: Guided process for uploading to EUDAMED portal.
UDI-DI (Device Identifier): Device name, GMDN code, risk class, issuing entity (GS1, HIBCC, ICCBBA), manufacturer & authorised rep.
UDI-PI (Production Identifier): Serial number, lot/batch, manufacturing date, expiry date, software version (SaMD).
Device Properties & Variants: Sterility, single-use, implantable, active device, latex/DEHP flags, packaging hierarchy.
Reusable Across Products: Share UDI structures across product families and packaging levels.
Single Data Model: Same data feeds your eTD, QMS, labels, and EUDAMED — no re-entry needed.
Standalone or Integrated: Use the full eTD suite or the UDI module only — your choice, switch anytime.
Validation Before Submission: Catches missing fields & EUDAMED-specific errors before XML export.
100% Traceability: Full audit trail connecting your Technical Documentation to EUDAMED registration.
Step 1 - Create Basic UDI-DIs: XML Upload 1 registers your product family — device name, GMDN, risk class, manufacturer details.
Step 2 - Create UDI-DIs: XML Upload 2 records every variant and packaging level, automatically linked to the Basic UDI-DI.
Upload-Ready Output: Result is clean, validated XML, no manual editing required.
Data Update Workflow: Track changes between versions and generate update XML for resubmission.
ERP Limitations: ERPs don't know EUDAMED validation rules, can't map Basic UDI-DI hierarchies correctly, miss country-specific fields.
Ongoing Maintenance: In-house solutions must be GxP-validated, and someone needs to maintain EUDAMED schema updates continuously.
CertHub Advantage: Validated solution with automatic schema updates, EUDAMED rules built-in, GDPR-compliant German servers.
ISO 80002-2 Validated: Compliant with EU MDR 2017/745 · Art. 27–30.
Automatic Data Reading: AI extracts product & UDI data from PDFs, Excel, Word, scanned forms and PLM/ALM systems.
Confidence Scores: Every extracted field comes with a confidence score and source reference for full transparency.
Review & Approve: Field-level validation with MDR guidance, you stay in control.
No Re-Entry: 80% less manual effort compared to typing data into EUDAMED directly.
Validated XML Output: CertHub generates EUDAMED XSD-validated, versioned XML automatically.
Real-Time Validation: Invalid XML cannot be downloaded, errors caught before export.
No IT Dependency: Your RA team never touches XML code, just upload the file to EUDAMED.
Step-by-Step Upload Checklist: Guided process for uploading to EUDAMED portal.
UDI-DI (Device Identifier): Device name, GMDN code, risk class, issuing entity (GS1, HIBCC, ICCBBA), manufacturer & authorised rep.
UDI-PI (Production Identifier): Serial number, lot/batch, manufacturing date, expiry date, software version (SaMD).
Device Properties & Variants: Sterility, single-use, implantable, active device, latex/DEHP flags, packaging hierarchy.
Reusable Across Products: Share UDI structures across product families and packaging levels.
Single Data Model: Same data feeds your eTD, QMS, labels, and EUDAMED — no re-entry needed.
Standalone or Integrated: Use the full eTD suite or the UDI module only — your choice, switch anytime.
Validation Before Submission: Catches missing fields & EUDAMED-specific errors before XML export.
100% Traceability: Full audit trail connecting your Technical Documentation to EUDAMED registration.
Step 1 - Create Basic UDI-DIs: XML Upload 1 registers your product family — device name, GMDN, risk class, manufacturer details.
Step 2 - Create UDI-DIs: XML Upload 2 records every variant and packaging level, automatically linked to the Basic UDI-DI.
Upload-Ready Output: Result is clean, validated XML, no manual editing required.
Data Update Workflow: Track changes between versions and generate update XML for resubmission.
ERP Limitations: ERPs don't know EUDAMED validation rules, can't map Basic UDI-DI hierarchies correctly, miss country-specific fields.
Ongoing Maintenance: In-house solutions must be GxP-validated, and someone needs to maintain EUDAMED schema updates continuously.
CertHub Advantage: Validated solution with automatic schema updates, EUDAMED rules built-in, GDPR-compliant German servers.
ISO 80002-2 Validated: Compliant with EU MDR 2017/745 · Art. 27–30.
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
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