MDIS gives importers structured access to manufacturer device records and documents so your team can check the same current record every time.
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.
MDIS keeps the device record, UDI context, and visible document set together in one workspace. That helps import teams review current documentation faster and keep the same reference point across the people involved in release decisions.
Keep the manufacturer, authorised representative, UDI fields, and retained release evidence on the same screen when your team is checking a device.
When a release question comes back later, the document history is already attached to the same device instead of buried in inbox history.
The same retained record shows the upstream manufacturer and authorised representative context so your team is not stitching the chain together manually.
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.
You search for the device, open the current record, and review the visible document detail your team is meant to use. Instead of chasing the latest file, you make the next release decision from one shared source of context.
1
Connect to the manufacturers whose records your team needs to review so the next step starts from one workspace.
2
Search for the device, open the current record, and review the visible documents in context.
3
Keep the visible record and document history attached to the same device so the team shares a common reference point.
4
Return to the same device record when something changes instead of rediscovering the latest version from scratch.
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.
Import teams do not need another filing system. They need one current record that the whole team can review consistently.
MDIS supports the full economic operator chain. Your authorised representative, distributors, and fellow importers can all access the same structured documentation.
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 update notifications when manufacturers republish
EUDAMED-linked context
Guided onboarding
Most Popular
For growing portfolios across multiple manufacturers
Everything in Starter
Bulk portfolio operations
Distributor and importer review queues
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
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.
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.
MDIS supports manufacturers from any country. Each manufacturer manages their own documentation. Your workspace gives you a unified view regardless of their location.
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.
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