Declarations of conformity, IFUs, labels and certificates arrive as releases, delivered to you with the date, so your team verifies the CE mark, UDI and Article 10(11) information before you make a device available.
Under EU MDR Article 14, distributors must verify CE marking, declaration of conformity, required labeling and instructions for use, and where relevant, assigned UDI details. Those checks are straightforward on paper and messy in practice when every manufacturer sends documentation differently.
MDIS does not change your obligations. It gives your team a better way to meet them by replacing scattered document requests with a device workspace that keeps the visible record, document status, and partner access in one place.
MDIS gives distributors one place for everything their manufacturers release to them. Open the device, see the delivered documents and their dates, and download what you need.
Manufacturers tick, per document, what you receive: typically the IFU, labelling and certificates.
Move straight into the device page, with the UDI fields and the current documents still attached.
Every release is kept exactly as it was delivered, so you can show what was in force on a given date.
Distributor users see only what each manufacturer released to them.
Keep UDI, Basic UDI-DI, class, and visible status attached to the device workspace your team is checking.
Every delivered release, with its documents and date, instead of whoever forwarded the latest file.
You search email for the manufacturer’s last package, discover it is stale, then start a new request cycle while the authority waits. The work turns into a scramble because the device detail, visible documents, and partner permissions all live in different places.
You open the device, see the release delivered to you and its date, and answer from the same record. Documents, UDI and delivery history are on one screen.
1
Connect to the manufacturers you work with so your team can retrieve device workspaces from one place.
2
Search for the device workspace, open the visible record, and review the documents your team is allowed to rely on.
3
Return to the same record when documents change instead of rediscovering the latest version from scratch.
4
Whether it is an internal review or an authority request, your answer starts from one visible workspace instead of a scramble.
Most distributors do not have large regulatory departments. MDIS is designed to make verification manageable without turning every request into a project.
When you invite manufacturers into MDIS, they release once and every partner works from the same delivered version.
Whether you work with 5 manufacturers or 500, the verification flow stays consistent because the device workspace does not change with every request.
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
No. When you invite a manufacturer, they can join at no cost. They only need a paid plan if they want to use MDIS independently.
If a manufacturer is already using MDIS with another partner, connecting to them is instant because the shared device workspace is already structured.
Declarations of conformity, CE marking status, labeling materials for your region, UDI data, and certificates. Manufacturers control what each partner sees.
MDIS keeps the visible device workspace and document context organised in one place so your team can review what is relevant without rebuilding the picture from multiple systems.
MDIS runs on ISO/IEC 27001 certified infrastructure. Documentation is stored with role based access so distributor teams work from the records made visible to them.
Email works until it does not. Documents get lost, versions become outdated, and teams stop trusting which file is current. MDIS replaces that with a controlled, traceable device workspace.
Book a 30 minute demo and we will walk you through how MDIS helps distributor teams verify from one visible workspace.
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