European Parliament regulation 2021/2226: everything medical professionals need to know




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 from a decade earlier (which continues to apply for products placed on the market prior to MDR). In the most part specific requirements have remained the same. But one line draws particular attention: Article 5 (12)

“Effective systems and procedures shall be in place to ensure that device users having downloaded instructions for use from the website can be informed in case of updates or corrective actions with regards to those instructions for use.”

It means that an eIFU system steps away from being a single direction document depository and becomes an active communication channel. While companies can try to leverage their existing communication channels and procedures, it will be quite challenging to cover all users in full – even if we forget about the efforts needed to perform these actions. When doing this outside of the eIFU system itself, one needs to register the changes made to documentation, cross reference them with the customer base (if known) and send out communications.

The IFUcare solution

IFUcare has resolved the gap between communications and clients via a new subscription module that each manufacturer can enable for their end users. This module allows the end user to subscribe to a specific product. They are then updated when a new document is added, an updated version of an existing document and even when a critical message is posted on the product. Since most end users (doctors, dentists, lab technicians and other healthcare professionals) work with a variety of products coming from a range of manufacturers, IFUcare has devised a convenient centralized location where they can manage all their subscriptions. It means end users can spend more time on work and by replacing their continued concern with having to look around and keep an eye out for any updates.

Additionally, an eIFU system support subscription ensures compliance with the 2021/2226 implementing regulation, removing the stress for the manufacturer as all required actions are automated – allowing them to focus on core activities. Once the manufacturer uploads new content for their products, the eIFU system collects all updates and sends a single daily overview with the applied changes. Within the IFUcare system these updates are collected across all of our manufacturers, ensuring end users receive a single daily update rather than burdening them with a flood of emails.

Protecting data

When implementing this kind of automated approach, the scope of data under control of an eIFU system becomes significantly more sensitive. Previously these systems only contained public information like the IFUs. But the subscription module also stores contact information and potentially login credentials of individuals. Consequentially the scope of the security controls has changed too; in addition to integrity and availability of data, they also consider confidentiality to ensure compliance with the GDPR regulation (2016/679) – intertwined with any subscription service.

So, while the 2021/2226 regulation may bring challenges to an eIFU system, it has the potential to be systematically resolved without impacting operations. Most importantly, it brings an opportunity to facilitate the needs of the consumer, customers and manufacturer – bringing all three closer together.

For more information on the developments in eIFU rules that companies need to know about, and how partnering with IFUcare can make things easier, download the whitepaper on this page.

Latest Intelligence