On December 14th, the European Parliament published regulation 2021/2226 – with significant implications for electronic instructions for use (eIFU) of medical devices. The publication replaces the 207/2012 regulations. One line draws particular attention: Article 5 (12) requiring effective systems to inform users of updates or corrective actions.
It means that an eIFU system steps away from being a single direction document depository and becomes an active communication channel.
The IFUcare solution
IFUcare has resolved the gap via a new subscription module that each manufacturer can enable for their end users. This module allows end users to subscribe to a specific product and receive automated notifications when content is updated. IFUcare devised a centralized location where end users can manage all their subscriptions across manufacturers.
Protecting data
When implementing this approach, the scope of data under control becomes significantly more sensitive. The subscription module stores contact information, so confidentiality must ensure compliance with GDPR regulation (2016/679). IFUcare provides a compliant solution that safeguards the interests of all parties.
