Manufacturers release declarations, IFUs, labels, certificates and UDI data once. Authorised representatives, importers and distributors receive exactly the documents meant for them, approve in order, and keep a sealed record of what they relied on under MDR Articles 11, 13 and 14. No email attachments, no outdated shared drives.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: every operator receives the same sealed release, and every approval and delivery is recorded with a date.
Every release your manufacturer sends is delivered to you with its EU Declaration of Conformity, IFU, labels and UDI: the information Article 14 asks you to verify. Each delivery is dated and kept exactly as it arrived, so you can hand an inspector a record instead of an email thread.
Releases from every manufacturer you represent arrive in one queue. Review the exact documents, mark findings at the spot, and approve. Delivery waits for you, and your approval is recorded as your Article 11 verification.
Prepare the release, tick which documents each authorised representative, distributor and importer can open, and press Release. Approvals come in order and delivery starts by itself. 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 before you place a device on the market, and keep the dated delivery record 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
Every release sealed, with full history on every document
Complete audit trail for every action, user, and document modification
Per-document access for each partner, set by the manufacturer
Automated compliance reminders and smart deadline management
Manufacturers release product information once, and it reaches every downstream operator they choose (authorised representatives, importers and distributors), each with exactly the documents meant for them and no duplication.
01
Add declarations, IFUs, labels and certificates to the device’s technical file. Each file is filed into its section by name.
02
Tick, per document, which authorised representative, distributor and importer can open it. New documents start with nobody.
03
The PRRC, the authorised representative and other approvers see the release one after another. They review the exact revision and mark findings at the spot.
04
After the last approval every partner holds the same sealed version, with the date it arrived. When a competent authority asks, everyone produces the same record.
MDIS starts by replacing the document handoff between economic operators. The same record then carries the EUDAMED registration, the public eIFU and post-market vigilance, without sending teams back to email and spreadsheets.
Releases, documents by section and language, registration and UDI identification on one device page.
An authorised representative sees every manufacturer they represent. A distributor sees only what each manufacturer released to it. A manufacturer ticks, per document, which partner can open it.
Approvers are asked one after another, and each decision is stamped with a user and a date. Blocking findings stop delivery until the manufacturer fixes them in the next release.
Find your company by SRN, import devices from EUDAMED, check each registration and generate the EUDAMED XML from the same device record.
Every release is kept exactly as it was delivered. You can show an auditor what was in force on a specific date, who approved it and which partners received it.
Import devices from EUDAMED or a spreadsheet. For large archives, MedQAIR engineers migrate IFUs and metadata with a scripted review before your team takes over.
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 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
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.
The software platform is designed to support the contracted Economic Operator, it can be used by the Legal Manufacturer to manage the downstream Economic Operators, such as the Authorised Representative, the Importer and the Distributor. Similarly, the software platform can be used to manage the upstream Economic Operators, such as an Authorised Representative or Distributor managing multiple Legal Manufacturers, and their provided Technical Documentation and or their Accompanying Documentation, such as the IFU and Product Label per Basic UDI and each consequent UDI-DI.
It is developed to ensure that the technical documentation and accompanying documentation of the Legal Manufacturers is available to each Economic Operator in the medical device distribution chain. In the event of Post-Market incidents, the Economic Operators have continuous access to the latest version of the Documentation, and the system will facilitate Vigilance reporting to regulatory databases, such as EUDAMED through the IMDRF coding systems.
The software platform is designed to support an effortless upload of technical documentation and accompanying documents to facilitate quick and easy sharing across Economic Operators. The technical documentation and accompanying documents are split into separate sections to ensure that each Economic Operator only gains access to those sections relevant to their duties, for example, the Distributor will only gain access to the Labeling materials relevant to their region.
The software platform is designed to automate registration into regulatory databases such as EUDAMED. Once all data for EUDAMED is present, it can be pushed through the EUDAMED API towards EUDAMED, any new UDI-DI added to the system can simply upload the new UDI-DI into EUDAMED, and into future supported databases, such as GUDID and SWISSDAMED.
If, for any need, access to documentation needs to be cancelled, the user can withdraw access. Note that there are legal obligations for Economic Operators for continued access, even when a contract with a Legal Manufacturer has been cancelled. As such information shared prior to end of contract date will continue to be accessible for the relevant Economic Operators.
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