The medical devices industry has been subject to a growing number of regulations. On one side is ensuring end users are informed about product updates. On the other, privacy regulations restrict what information can be shared. Both types of regulation are in place to ensure data is deployed safely and consensually.
Overcoming challenges
With Regulation 2021/2226, end users must be alerted whenever documents are updated. Manufacturers must ensure: end users can opt in and out, information updates are limited, information is used solely for notifying, and information is protected from tampering.
IFUcare combines the best of both worlds
IFUcare provides end users with an option to subscribe using an email address, stored in encrypted databases. Updates are sent automatically – quick, secure, and informative. Fundamental rights like the right to be forgotten are enforced.
Finding advantages
eIFU offers a direct channel for end users, providing fertile ground for post-market surveillance (PMS) while protecting privacy. IFUcare focuses on overall interactions rather than individual end users, allowing manufacturers to compare metrics while protecting user privacy.
