Review EUDAMED-linked fields on the workspace
UDI-DI and Basic UDI-DI sit beside the released documents and the registration status on the device page.
MDIS by MedQAIR
Keep the EUDAMED registration and XML attached to the same device record.
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.
Built for Your Role
EUDAMED data is only useful when your team can review it in context.
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.
Keep EUDAMED-linked context attached to the working device workspace
Check the registration before you release
Check registration flags what’s missing or wrong, down to a Basic UDI-DI whose GS1 check digit doesn’t match.
EUDAMED's guidance on every question
Each registration question carries EUDAMED’s own help text and field reference, and the XML is generated from the released record.
One working record
What MDIS does today, and what it does next
EUDAMED
EU actor, UDI, and device registration context.
GUDID
US device identifier preparation and records.
Swissmedic
Future scope for teams that want to reuse the same device-data foundation across markets.
MHRA DORS
Future scope for extending the same structured workspace into additional regulatory contexts.
Health Canada
Future scope built on the same device-data model rather than a separate manual spreadsheet trail.
AusUDID
Future scope for teams that want one device workspace to support broader market readiness.
The same workspace matters to different teams for different reasons
Manufacturers
Keep the working workspace your team uses aligned with the EUDAMED-linked context visible in MDIS.
Authorised Representatives
Review linked manufacturer records with UDI and status context visible beside the same device detail your team is already checking.
Distributors and Importers
Check EUDAMED-linked context beside the documents and device details your team already reviews operationally.
Pricing
Pricing that grows with your network
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.
Starter
€199/month
For distributors with a focused manufacturer portfolio
Start Trial- 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
Growth
€899/month
For growing portfolios across multiple manufacturers
Start Trial- Everything in Starter
- Bulk portfolio operations
- Distributor and importer approvals
- Read-only API access
- Guided onboarding support
Scale
€2,999/month
For large or operationally complex portfolios
Contact Sales- 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.
Structured Article 11 evidence across represented manufacturer portfolios.
Starter
€199/month
For ARs with a small manufacturer portfolio
Start Trial- 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
Growth
€899/month
For growing AR portfolios needing operational scale
Start Trial- Everything in Starter
- Bulk device import from EUDAMED
- Bulk portfolio operations
- Read-only API access
- Guided onboarding support
Scale
€2,999/month
For large AR portfolios managing hundreds of manufacturers
Contact Sales- 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
Invite represented manufacturers at no cost and manage the portfolio from one workspace.
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.
Starter
€199/month
For manufacturers managing their own partner network
Request Invite- 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
Growth
€899/month
For multi-device or multi-market manufacturers
Start Trial- Everything in Starter
- Bulk device and documentation management
- Read-only API access
- Guided onboarding support
Scale
€2,999/month
For large or operationally complex manufacturer portfolios
Contact Sales- 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 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 Contact Sales ↗
Frequently Asked Questions
Find answers to common questions about our services, compliance processes, and how we can assist your business.
What can I see in MDIS today?
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.
Why does that matter operationally?
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.
Does MDIS submit to EUDAMED?
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.
How does this relate to other databases?
The idea is to build from one structured device workspace so future database work does not require a separate disconnected process for each market.
Can I start with MDIS before broader database work lands?
Yes. Start by finding your company in EUDAMED and importing your devices. Registration and XML follow on the same record.