Find your company by SRN, import devices from EUDAMED, check each registration before release and generate the EUDAMED XML from the released record, all beside the same device technical file.
Regulatory teams do not just need UDI values. They need to see those values beside the working device record, the visible documents, and the operational context their colleagues are already using. When that picture is split across different systems, confidence drops and follow-up work rises.
XML preparation is part of the same reality. Teams still need a clear device workspace around the export step so they can understand what they are generating and why.
MDIS keeps EUDAMED-relevant fields attached to the same workspace your team already uses operationally. That means UDI context, class, visible document state, and XML export steps can be reviewed together instead of piecing together a device story from multiple tools.
UDI-DI and Basic UDI-DI sit beside the released documents and the registration status on the device page.
Check registration flags what’s missing or wrong, down to a Basic UDI-DI whose GS1 check digit doesn’t match.
Each registration question carries EUDAMED’s own help text and field reference, and the XML is generated from the released record.
MDIS starts by replacing the document handoff between economic operators. From there, the same record can support broader registration, publication, and verification workflows without sending teams back to email and spreadsheets.
Company lookup by SRN, device import, registration checks and XML generation, beside the working device record.
A future extension of the same structured workspace rather than a separate disconnected process.
Future scope for teams that want to reuse the same device-data foundation across markets.
Future scope for extending the same structured workspace into additional regulatory contexts.
Future scope built on the same device-data model rather than a separate manual spreadsheet trail.
Future scope for teams that want one device workspace to support broader market readiness.
Keep the working workspace your team uses aligned with the EUDAMED-linked context visible in MDIS.
Review linked manufacturer records with UDI and status context visible beside the same device detail your team is already checking.
Check EUDAMED-linked context beside the documents and device details your team already reviews operationally.
All plans include MedQAIR’s ISO 27001 certified infrastructure, document exchange, version history, and verification evidence.
EUR 199/month can cost less than one failed distributor check. Replace manual verification work across your network.
Your manufacturers can join MDIS at no cost when you invite them to share documentation.
For distributors with a focused manufacturer portfolio
Verification workspace per manufacturer
Portfolio overview across all manufacturers
Access to declarations, IFUs, labels, certificates, and UDI data
Automatic delivery when manufacturers release
EUDAMED-linked context
Guided onboarding
Most Popular
For growing portfolios across multiple manufacturers
Everything in Starter
Bulk portfolio operations
Distributor and importer approvals
Read-only API access
Guided onboarding support
For large or operationally complex portfolios
Everything in Growth
Advanced bulk onboarding and update tools
Full API access (read and write)
Priority support
Assisted onboarding with data import
Represent unlimited manufacturers. Every manufacturer you invite can join MDIS at no cost.
For ARs with a small manufacturer portfolio
Verification workspace per manufacturer
Article 11 evidence trail across represented manufacturers
Documentation access and sharing
EUDAMED-linked context and XML workflow support
Certificate and expiry tracking
Manufacturer invitations at no cost
Guided onboarding
Most Popular
For growing AR portfolios needing operational scale
Everything in Starter
Bulk device import from EUDAMED
Bulk portfolio operations
Read-only API access
Guided onboarding support
For large AR portfolios managing hundreds of manufacturers
Everything in Growth
EUDAMED M2M submission
Advanced bulk onboarding and update tools
Full API access (read and write)
Assisted onboarding with data import
Priority support
If a distributor or authorised representative invited you to MDIS, you already have free access. Paid plans are for manufacturers managing their own partner network.
For manufacturers managing their own partner network
Shared compliance workspace
Publish once to distributors, authorised representatives, and importers
Document versioning and partner access control
EUDAMED-linked context
EUDAMED XML workflow support
Certificate and expiry tracking
Automatic partner notifications on updates
Guided onboarding
Most Popular
For multi-device or multi-market manufacturers
Everything in Starter
Bulk device and documentation management
Read-only API access
Guided onboarding support
Guided onboarding
For large or operationally complex manufacturer portfolios
Everything in Growth
Full API access (read and write)
Advanced bulk onboarding and update tools
Assisted onboarding with data import
Priority support
MDIS is free for small importers and for manufacturers invited by a paying distributor or authorised representative.
MDIS is priced to build the network, not to block it. Small importers can use MDIS at no cost, and manufacturers invited by a paying distributor or authorised representative can join at no cost as well. Paid plans are for organisations running broader partner networks, higher device volumes, and more structured compliance workflows.
Enterprise: For organisations requiring custom integrations, SLAs, or dedicated onboarding
Company lookup by SRN, device import from EUDAMED, the full device registration with EUDAMED’s own guidance on each question, registration checks before release, XML generation, and an on-demand comparison with EUDAMED.
Because your team can review the context it needs in the same workspace as the visible document set instead of reconstructing the picture from multiple tools.
MDIS produces the EUDAMED XML from the released registration and compares the stored record with EUDAMED on demand. Machine-to-machine submission is part of the Scale plan for authorised representatives.
The idea is to build from one structured device workspace so future database work does not require a separate disconnected process for each market.
Yes. Start by finding your company in EUDAMED and importing your devices. Registration and XML follow on the same record.
Book a demo and see how EUDAMED-linked context fits into the wider MDIS workflow.
Cookies help us improve your experience on our website. By using our site, you consent to the use of cookies as described in this policy.
