Frequently Asked Questions

What are eIFU and their scope?

eIFU refers to 'electronic instructions for use' and encompasses various regulatory documents, including certificates of analysis and safety data sheets. eIFUApp provides a validated website compliant with regulations, ensuring maintenance and corporate identity alignment.

Why should I opt for eIFU over paper instructions?

eIFU offers advantages such as environmental friendliness, faster document updates, reduced recall risks, cost savings associated with paper, and alignment with technological advancements.

Are my products eligible for eIFU?

Medical devices and in vitro diagnostics require instructions for use. Products falling into these categories can opt for eIFU.

Is it challenging to get started with eIFUApp?

Getting started with eIFUApp is user-friendly. Our support team offers training, access to manuals, a test site for practice, and comprehensive assistance to streamline implementation.

What regulations apply to my medical device / in vitro diagnostic?

Applicable regulations vary by country. eIFUApp ensures compliance with regulations for eIFU across multiple market countries.

Can I host my company's eIFU on our own website?

Possible, but strict regulatory compliance requires a validated, secure, and user-friendly website, along with continuous updates. Outsourcing to eIFUApp offers a hassle-free and compliant solution, letting you focus on your core business.