Review exactly what was shared with you
Your manufacturer ticks, per document, what you receive. The device page shows those documents beside the UDI-DI and Basic UDI-DI.
MDIS by MedQAIR
Review the device record before you release it.
Your non-EU manufacturers release their documents to you in MDIS. Your team opens the same current record every time, and every delivery keeps its date.
Built for Your Role
You rely on documentation that sits outside your systems.
Importers still need the same current device and document context every time a release decision is made. The difficulty is that the record often lives with a manufacturer in another country, in a system your team does not control, and the version you received last month may not be the version you should rely on today.
Review current records without reconstructing the story each time
Hold the current version trail
Every release is frozen as shipped, with the date it reached you, so a release question that comes back later is answered from the record.
Check the wider operator chain when needed
Approvals run in order: the PRRC, the authorised representative and you are each asked in turn, and the record shows who approved and when.
What happens when a shipment arrives at customs?
Without MDIS
A shipment arrives from a non-EU manufacturer. You need to verify documentation before releasing it. You email the manufacturer for the latest DoC. You check your files for the certificate, but it might be expired. Three days later you are still waiting for a response while the shipment sits in your warehouse.
With MDIS
You open the device, see the release delivered to you with its declaration of conformity and IFU, and make the release decision from the current record.
One working record
Connect to your manufacturers
Invite your non-EU manufacturers
Create the connection and establish the device portfolio.
Review device documentation
Check released records and registration context.
Record your approvals
Retain evidence of the checks your organisation performed.
Stay current automatically
Receive subsequent approved releases in the same workspace.
Built for the way importers actually work
Your manufacturers join at no cost
When you invite a non-EU manufacturer, they get a free workspace to upload documentation. This removes the biggest barrier to getting manufacturers to share.
Shared current record
Import teams do not need another filing system. They need one current record that the whole team can review consistently.
Works alongside your AR
MDIS supports the full economic operator chain. Your authorised representative, distributors, and fellow importers can all access the same structured documentation.
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.
How is the importer page different from the distributor page?
The importer story focuses on making release decisions from the current record. The underlying value is similar: structured access to the device and document context your team needs.
Do my non-EU manufacturers need to use MDIS?
When you invite a manufacturer, they can join at no cost. They upload their documentation once and it is available to you and any other connected partners.
What if I import devices from manufacturers in multiple countries?
MDIS supports manufacturers from any country. Each manufacturer manages their own documentation. Your workspace gives you a unified view regardless of their location.
Is my data secure?
MDIS runs on ISO/IEC 27001 certified infrastructure. Documentation is stored with role based access so importer teams review the records made visible to them.