MDIS gives authorised representatives one list of releases from every manufacturer they represent. Review the exact documents, mark findings at the spot, and approve. Delivery waits for your approval.
Every manufacturer sends documentation differently. Some use email, some use portals, some send nothing until you chase them. When you represent 10, 20, or 50 manufacturers, each with multiple devices, the operational overhead of collecting, organizing, and verifying documentation becomes a full time job. And when a competent authority contacts you, you need to produce proof across your entire portfolio, not just one manufacturer.
MDIS gives authorised representatives one place for the releases of every manufacturer they represent: the exact documents, the findings and the approval, together. Instead of piecing evidence together from separate sources, your team approves from the record itself.
Devices grouped by manufacturer, each with its Basic UDI-DI and status: released, waiting for your approval, or in draft.
Open the frozen release documents, read the PDF of the exact revision, and mark the region that needs attention. Request changes and delivery stops until the manufacturer fixes it.
Your approval is recorded, with its date, as your Article 11 verification of that release. Findings carry into the next release until they are addressed, so your team answers competent authorities from evidence, not memory.
Import the devices of the manufacturers you represent from EUDAMED, with UDI and status beside the record you review.
Use one review workspace across linked manufacturers instead of maintaining separate filing systems for each portfolio.
Findings, approvals and delivery states keep follow-up work moving without losing context.
The authority asks for documentation on a device from one of your manufacturers. You search your email and shared drive for the latest package. The declaration of conformity is from two years ago. You contact the manufacturer and wait for a response. Days pass. The authority follows up. You spend the week piecing together documents from multiple sources.
You open the device and see which release was delivered and what you approved, with the documents and UDI on the same screen. Your team responds from the record, the same day.
1
Connect to the manufacturers you represent so your team can open their device records from one workspace.
2
Open the queued item, inspect the linked device record, and review the visible document set in context.
3
Keep status comments and recorded review outcomes attached to the device record so the next step is visible to the team.
4
When a competent authority contacts you, open the linked record and answer from the same workspace your team already reviewed.
MDIS is designed for ARs who manage portfolios across many manufacturers. The more manufacturers you represent, the more time MDIS saves.
When you invite a manufacturer, they get a free workspace to upload documentation. This removes the biggest barrier to adoption.
EU MDR expects ARs to show what they reviewed. MDIS records each approval, with its date, as your verification of that release.
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
Manufacturers you invite join MDIS at no cost. They only need a paid plan if they want to use MDIS independently with their own partner network.
MDIS is purpose built for regulatory document exchange. It structures documentation by device, keeps review work visible, and keeps record history attached to the device instead of scattering context across inboxes and folders.
Yes. MDIS handles the document exchange layer between you and your manufacturers. It complements your QMS rather than replacing it.
They start a new change and release it. It arrives in your list for approval, with any earlier findings carried over and marked addressed.
There is no limit. MDIS is designed to scale with your portfolio. Pricing is based on your organisation’s tier, not per manufacturer.
Book a 30 minute demo tailored to the AR workflow.
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