See the whole represented portfolio
Devices grouped by manufacturer, each with its Basic UDI-DI and status: released, waiting for your approval, or in draft.
MDIS by MedQAIR
See which manufacturer releases need your approval.
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.
Built for Your Role
The more manufacturers you represent, the harder compliance gets.
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.
Operational oversight across linked manufacturers
Review the exact revision you approve
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.
Keep dated evidence with the record
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.
More than a shared folder
Bulk device import
Import the devices of the manufacturers you represent from EUDAMED, with UDI and status beside the record you review.
Portfolio dashboard
Use one review workspace across linked manufacturers instead of maintaining separate filing systems for each portfolio.
Structured onboarding
Findings, approvals and delivery states keep follow-up work moving without losing context.
When a competent authority contacts you
Without MDIS
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.
With MDIS
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.
One working record
From linked manufacturer access to review completion
Invite your manufacturers
Connect represented companies and their device portfolios.
Review each device portfolio
Open the released documentation and registration context.
Track findings to the fix
Coordinate observations and replacement evidence.
Respond to authorities with confidence
Retrieve the exact approved record and dated history.
Built for the way authorised representatives actually work
You represent multiple manufacturers
MDIS is designed for ARs who manage portfolios across many manufacturers. The more manufacturers you represent, the more time MDIS saves.
Your manufacturers join at no cost
When you invite a manufacturer, they get a free workspace to upload documentation. This removes the biggest barrier to adoption.
You need to prove what you checked
EU MDR expects ARs to show what they reviewed. MDIS records each approval, with its date, as your verification of that release.
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.
Do my manufacturers need to pay?
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.
How is MDIS different from managing documents in SharePoint or email?
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.
Can I use MDIS alongside my existing QMS?
Yes. MDIS handles the document exchange layer between you and your manufacturers. It complements your QMS rather than replacing it.
What happens when a manufacturer updates a document?
They start a new change and release it. It arrives in your list for approval, with any earlier findings carried over and marked addressed.
How many manufacturers can I manage in MDIS?
There is no limit. MDIS is designed to scale with your portfolio. Pricing is based on your organisation’s tier, not per manufacturer.