Manufacturers publish declarations, IFUs, labels, certificates, and UDI data once. Distributors, authorised representatives, and importers verify and access the correct version against their obligations under MDR Articles 11, 13, and 14, without chasing email attachments or outdated shared drives.
Manufacturers hold the source. Authorised representatives are accountable for it under Article 11. Distributors must verify it under Article 14 before making a device available. Importers must check it under Article 13 before placing it on the market. In practice, each of these checks runs on forwarded emails, expired download links, and documents that may no longer be the approved version.
When a competent authority asks a question, none of the parties can prove they were looking at the same thing. MDIS closes that gap by giving every operator access to the same approved document set, the same publication history, and the same verification trail.
Confirm the CE mark, EU Declaration of Conformity, UDI, and the information required under Article 10(11) are present and current. Every verification is recorded with a date and a user, so you can hand an inspector a trail instead of an email thread.
Verified technical documentation for every manufacturer in one place. Respond to competent authority requests in minutes, not days. Keep evidence of your Article 11 verification duties on the same record your team already uses.
Publish an approved version of each document one time. Every authorised representative, distributor, and importer you work with gets notified automatically, accesses the current version, and confirms receipt. Stop sending the same zip file to the same partners every six months.
Confirm under Article 13 that the manufacturer documentation and UDI are in order, and hold proof of that check for six years. MDIS is free for small importers.
Shared folders and spreadsheets might seem convenient, but they create serious compliance and operational risks that compound over time.
No version control — anyone can overwrite critical compliance data
No audit trail — impossible to prove what changed, when, and by whom
No role-based access — sensitive regulatory data exposed to all
No automated reminders — compliance deadlines are easily missed
Full version history with automatic change tracking on every document
Complete audit trail for every action, user, and document modification
Role-based access control with granular, operator-specific permissions
Automated compliance reminders and smart deadline management
Manufacturers publish product information once and it becomes instantly accessible to all downstream operators in their network — distributors, authorised representatives, and importers — all with role-appropriate access levels and no data duplication.
01
Declarations, IFUs, labels, certificates, and UDI data are uploaded to the device, with an approved version and a publication date.
02
Every connected authorised representative, distributor, and importer sees the new version in their own workspace, with a clear indication of what changed.
03
The platform shows the Article 14, 13, or 11 checks that apply to the reader role and records who confirmed what.
04
When a competent authority asks, every party can produce identical documentation and a dated verification trail.
MDIS starts by replacing the document handoff between economic operators. From there, the same record can support broader registration, publication, and verification workflows without sending teams back to email and spreadsheets.
Keep device detail and supporting documents together instead of splitting the story across inboxes and folders.
An authorised representative sees every manufacturer they represent. A distributor sees only what each manufacturer chose to share. A manufacturer decides, per document, which partner can view or download.
Track every verification a distributor, AR, or importer is legally required to perform. Each check is stamped with a user and a date, and reopens automatically when a document version is superseded.
Keep UDI, Basic UDI-DI, class, and status beside the same device record your team uses operationally.
Every version of every document is retained. You can show an auditor what was in force on a specific date, who approved it, and which partners had access.
For large manufacturer archives, MedQAIR engineers migrate IFUs and metadata with a scripted review process before your team takes over ongoing API updates.
MDIS was built by medical device regulatory professionals who audit manufacturers for a living. The people behind the platform know what distributors, authorised representatives, and importers are actually required to prove, because they have stood on both sides of the conversation.
A major European PACS and AI distributor has joined MDIS as a founding partner and covers guest access for its manufacturer network.
Small importers never pay. Manufacturers invited by a paying distributor or authorised representative never pay. That is how you grow the network without forcing every partner through a procurement cycle.
Documentation and verification evidence are held in infrastructure audited against ISO 27001, and the certification can be shared with your QA team on request.
MDIS was co-founded by regulatory professionals with hands-on experience as authorised representatives and QMS auditors, so edge-case questions get answered by people who have met them in practice.
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
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
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