MDIS gives manufacturers one technical file per device. Prepare each release, choose what every distributor, importer and authorised representative receives, and let delivery start by itself once the approvals are in.
Your distributors, authorised representatives, and importers all need documentation to meet their own obligations. Today that often means answering the same request repeatedly through email, portals, and ad hoc follow up whenever a certificate, DoC, or labeling file changes.
The real cost is not just the time spent sending files. It is the uncertainty about whether partners are still relying on the right version once the document leaves your hands.
MDIS turns each device’s technical file into the shared source of truth your partners work from. Release the document set once, control per document which economic operator receives it, and stop rebuilding the package for every request.
Releases, documents by section and language, registration and UDI identification sit on one device page, the same record your partners receive from.
A grid of documents by partner shows exactly who will receive what before you release. A distributor can get the IFU and certificates while your authorised representative gets the full file.
A released version is sealed. When partners or auditors ask what changed, the release history shows what each partner received and when.
You receive the renewed certificate, update your internal files, then start emailing the same package to distributors, authorised representatives, and importers. Some ask for additional context, some never confirm receipt, and weeks later you still do not know who is working from the old version.
You add the renewed certificate to a change and release it. Your authorised representative approves, and every partner receives it as soon as the last approval is in. No repeat packaging, no follow-up emails.
Most manufacturers start with MDIS because a partner invited them. The same record model can then support broader device-data and document workflows without changing how your team works.Extend the same controlled document model into electronic instructions for use when your team is ready.
Publish the IFUs from a release on a public page per device, with a QR code for the label.
Find your company by SRN, import devices from EUDAMED, and check each registration before it is released.
Every release is sealed and kept, so you never reconstruct what changed from email threads.
Start with one controlled record model, then extend that same structure into broader market and partner workflows over time.
Most manufacturers join MDIS because a distributor or authorised representative invites them. Here is how that relationship turns into a shared working record.
A partner invites you into MDIS, or you find your company in EUDAMED by SRN and claim it.
Add the documents your partners need. Each file is filed into its section by name.
Partners are invited once and reused on every device, so a new partner needs no new packaging.
Release, let the approvals come in, and start a new change whenever a document changes.
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
Yes. When a distributor, authorised representative, or importer invites you, you get a free workspace. You only need a paid plan if you want to use MDIS independently.
If you want to proactively manage your partner network through MDIS rather than waiting for invitations, you can upgrade to a manufacturer plan that gives you full control.
Yes. For every release you tick, per document, which partner receives it. New documents start with nobody.
MDIS runs on ISO/IEC 27001 certified infrastructure. Documents are stored with role based access controls so partners only see what your team makes visible.
Book a 30 minute demo and see how simple partner-facing document sharing can be.
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