MDIS gives authorised representatives a linked workspace to find manufacturer devices, open the current record, and move review work forward.
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 linked workspace for manufacturer records, visible documents, and queued review work. Instead of piecing together evidence from separate sources, your team can move from the queue to the underlying device record in one flow.
Start from one manufacturer view that shows who is current, who is pending, and where Article 11 review follow-up is due next.
Move from the portfolio into the shared device detail where UDI context, approved documents, and partner checks stay attached to the same record.
Version history, approval dates, and partner access stay visible so your team can answer competent authorities from evidence, not memory.
Keep EUDAMED-linked device context visible beside the record your team is already reviewing.
Use one review workspace across linked manufacturers instead of maintaining separate filing systems for each portfolio.
Use visible review states and linked access to 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 pending review queue, select the linked device, and review the current record in context. UDI data, visible documents, and current review state are on the same screen, so your team responds from evidence instead of memory.
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 keeps visible review context and dated record history attached to the device itself.
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
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.
Your team sees the updated device record and can review the current visible documents in the same workspace instead of reconstructing what changed from email threads.
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.
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.
