eIFU (electronic instructions for use) are the mandatory instructions of a medical device provided digitally instead of on paper. DocuLiv is a comprehensive eIFU platform for manufacturers — compliant with MDR 2017/745 and Regulation (EU) 2021/2226, without tons of paper.
Ensures compliance with regulatory requirements of Regulation (EU) 2021/2226 and ISO 27001 security standard.
Manufacturers eliminate costs for printing, packaging and distribution of manuals and other product information.
Product information is available anytime and anywhere with internet connection.
Support for 24 language versions enables seamless operation in all EU countries. Additional languages can be added.
User-friendly interface in corporate colors and design on custom second or third level domain.
We provide operation, technical support, regular updates and protection of processed data.
DocuLIV is a complete cloud solution that can be implemented quickly and without costs associated with purchasing special hardware. We guide you through the entire process of digitizing product information and connecting to your information systems. Implementation typically takes place in 4 steps.
We describe how you work with product information, analyze the current level of digitization and propose the eIFU implementation procedure.
Product information needs to be linked with production information and ensure that product packaging is clearly marked with the corresponding QR code and URL.
DocuLiv runs in the cloud with high availability, 24/7 monitoring and security. You access the system on your own domain, e.g. doculiv.yourdomain.com.
After performing integration and security tests, we launch the system into production and take care of its operation, backup and regular updates.
The manufacturer enters product information into the DocuLIV system, which includes manuals, certificates, but also training materials and production data that identify the type, production batch or serial number.
The system then enables linking production data with product information and can generate materials for product packaging labeling.
The customer or user can therefore download always current information about the product with knowledge of the type and serial number.
DocuLIV enables both updates and versioning of product information, so one product type can have different manuals depending on the production batch or number.
All actions, updates and operations with product information are logged in the system, and entered product information can additionally be marked with a timestamp or signed with a digital certificate.
Each batch can have a different version of documentation
Complete logging of all operations
Timestamps and certificates
Transparent pricing model.
Meets all requirements
No limits
ISO 27001 certified
Automatic and free
Contact us for an individual quote.
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eIFU (electronic instructions for use) means providing the mandatory instructions for a medical device in digital form instead of paper — typically via the manufacturer's website or a dedicated portal where users find the document by REF or UDI code. Read our guide What is eIFU?
Yes. MDR 2017/745 together with Implementing Regulation (EU) 2021/2226 defines when instructions for use may be provided electronically. Since 16 July 2025, Implementing Regulation (EU) 2025/1234 extends this option to all medical devices intended for professional users.
All medical devices intended for professional use — including Annex XVI products and legacy devices under the MDR transitional provisions. Devices intended for lay users still require paper instructions.
Only for lay users. For professional users, a paper copy must be provided free of charge on request — your eIFU process has to be able to handle such requests.
DocuLiv is a cloud service — there is no hardware to buy and nothing to install. Implementation time depends on the size of your portfolio; you can choose self-service or full-service data migration by our team.
Pricing is based on the number of products (SKUs), language versions and the support level you choose. See the pricing page and request a quote tailored to your portfolio.