Manage IFU versions, languages and access
Assign instructions to a catalogue number and batch. Previous versions remain available, and changes are logged. Healthcare professionals open the right IFU by scanning the code or searching for the device.
The right IFU in seconds
QR code on the label or delivery note, search by REF, UDI, product name or serial number. The portal runs in your corporate design, and from the Pro plan on your own domain.
Multiple brands, large catalogues
Pro and Enterprise include unlimited products, brands and languages, with no per-product-line fees. Basic covers up to 1,000 catalogue numbers (REF).
All 24 EU languages
Every language version per market, batch and REF, with more languages on request. Each manufacturer publishes the languages of the markets it sells to: MEDIN in 24, Quartett in 20.
Every version traceable
Versions per batch, superseded versions kept retrievable with their dates, every change logged. Validation documentation templates for your QMS are included in every plan. Digital signatures and timestamps in the Enterprise plan.
For clinicians and sales reps
Next to the public IFUs there are areas with their own login: one for healthcare professionals, for example for IFUs intended for professionals only, and one for your sales reps.
UDI and product data checked
DocuLiv checks UDI-DI and product data against EUDAMED and flags discrepancies, so your label, your registration and your IFU stay consistent (Pro and up).
Requests straight from the portal
Professional users request a paper copy directly in the portal. Under Regulation (EU) 2021/2226, the manufacturer provides it free of charge within the time set in its risk assessment, at the latest within 7 calendar days of receiving the request.
Connected to your systems
REST API for automatic import and updates from your PIM, ERP or production systems (Enterprise), automatic sync from cloud storage (Pro and up).
Who reads what
Logging and access statistics show which IFUs are requested in which markets (Pro and up).
We run it, you publish
Hosted in the EU, 99.9 % availability, 24/7 monitoring, backups in two locations, regular updates. Details on the Security page.
Live in as little as 2 weeks*, typically 4–8 weeks.
- 01Process auditHow you work with IFUs and product data today.
- 02Data connectionProducts, batches and documents linked, QR code and URL for your label.
- 03TestingIntegration and security tests before go-live.
- 04Go-live and operationWe run, monitor and update the portal.
* Depends on the volume of data and how quickly it is delivered. With Basic, you upload your instructions yourself. For Pro and Enterprise, we map your processes together and test the portal before launch. The scope of data migration and integrations is agreed based on your data.
Frequently asked questions
How do users find the right IFU?
They scan the QR code on the label or delivery note, or enter the REF, UDI, product name or serial number. DocuLiv shows the version valid for that batch in the user's language.
Can some documents be restricted to healthcare professionals?
Yes. Protected areas with their own login hold content for clinicians, for example IFUs intended for professionals only, and for your sales reps.
Does DocuLiv connect to our PIM or ERP?
Yes. Enterprise includes automatic updates via a REST API, Pro syncs automatically from cloud storage, and Basic uses manual updates.
What happens to superseded versions?
They stay retrievable with their dates and every change is logged, as Regulation (EU) 2021/2226 requires.
See the platform with your own products.
30 minutes, online.