Versioned instructions with effective dates
An instruction change applies from the date you set, and each batch keeps its own version as evidence.
Medical and dental devices
Instructions, UDI and safety notices behind one code
A professional user scans the code and gets the instructions valid for their batch. You change the instructions once and send a field safety notice with a reach counter.
What the regulation says
(UE) 2017/745 — wyroby medyczne, UDI
Legal text on EUR-Lex · As of
Checklist
Each obligation with its legal basis and how Itemoo handles it.
Instructions for use
MDR zał. I rozdz. III pkt 23; (UE) 2021/2226The device comes with instructions for use. For devices intended for professional users, electronic instructions (eIFU) are allowed under Regulation 2021/2226, including a paper copy on request.
In Itemoo: A versioned library of instructions with effective dates, the version pinned to the batch, and the same address for the device’s whole service life.
UDI carrier
MDR art. 27The device and its packaging bear a unique device identifier (UDI) in human- and machine-readable form.
In Itemoo: A GS1 Digital Link code with GTIN, batch and serial number. We do not register devices in EUDAMED — that stays with the manufacturer.
Field safety corrective actions
MDR art. 89The manufacturer informs users about field safety corrective actions (field safety notice).
In Itemoo: A banner on scans of the batch or serial range, notifications and a reach counter for holders.
Post-market surveillance
MDR art. 83The manufacturer systematically gathers information on how the device performs on the market.
In Itemoo: The “Report a problem” form and questions on every product page reach the panel attached to the scanned code.
This is a summary of obligations, not legal advice. The manufacturer remains responsible for product compliance and document content.
In Itemoo
GS1 Digital Link as the UDI carrier
One code with GTIN, batch and serial number — read by tills, scanners and phones.
Content for professionals
The page can ask whether the visitor is a healthcare professional before showing information meant for them.
Frequently asked questions
Does Itemoo register devices in EUDAMED?
No. EUDAMED registration and Basic UDI-DI assignment stay with the manufacturer. Itemoo provides the UDI carrier and the product page with documents.
Can I provide instructions in electronic form only?
Only in the cases and under the conditions of Regulation 2021/2226 — among others for devices intended for professional users, with a risk assessment and a paper copy on request. Itemoo provides a stable address and version history; the decision and assessment stay with the manufacturer.
How does a field safety notice work?
You announce the action for a batch or a serial range. Every scan shows a banner with instructions, holders with notifications on get a message, and a counter shows how many people have seen it.
Bring one product. Leave with a working code.
For the demo we take your product’s documents, import them live, and show you the finished product page together with a code you can scan immediately. Thirty minutes, no slide deck.
No card, no commitment, no fifteen-email sales funnel.