Clarification on Applicability of (EU) 2025/1234 Amendment to Regulation (EU) 2021/2226 (E-IFU)

[Georgethebest]

Hi all,

With the recent release of Regulation (EU) 2025/1234, which amends Regulation (EU) 2021/2226 on the provision of instructions for use (IFU) in electronic form for medical devices, I wanted to check whether my understanding is correct and hear how others interpret its practical applicability.

From what I can tell, the amendment now limits Article 9 to a single requirement:

“Instructions for use in electronic form, which are provided in addition to complete instructions for use in paper form, shall be consistent with the content of the instructions for use in paper form.”

This appears to mean that if a manufacturer supplies a full paper IFU with the device and additionally makes the same IFU available online, they no longer need to comply with the more demanding conditions originally outlined in 2021/2226.


Am I understanding this correctly, that this amendment introduces a much lighter requirement for optional e-IFU availability, without additional regulatory burden?

Thanks in advance for any insights or interpretations.

 

[EmiliaBedelia]

I agree with your interpretation. Realistically though, GDPR is still applicable in its own right as a regulation.... so you do not actually get away from that. Also, it's still a requirement from MDR itself that the information supplied by the manufacturer must be placed on the website if the manufacturer has one. So it is not really "optional" in that regard.

IMO the biggest benefit from Regulation (EU) 2025/1234 is that NBs will not be wasting time checking these requirements during conformity assessment. Anything they can do to cut down those review times is a good thing.