March 22, 2022

EU eIFU Regulation: Broader Than Many Think

Everyone seems to know that Europe’s Regulation (EU) 2021/2026 covers requirements for when eIFU are provided instead of paper IFU.  But did you know that the Commission also demands a certain level of conformity with that Regulation also for when eIFU is provided in addition to paper IFU?  Here’s an overvierw.

Specifically, the Commission’s Directorate General for Health and Food Safety told me that if ever an eIFU is provided for medical devices in the Union, whether the eIFU is provided instead of paper (for qualifying Article 3 devices) or else in addition to paper (for any devices), then the applicable provisions of Regulation (EU) 2021/2226 always apply.  Plainly, eIFU may not be provided outside the scope and applicable provisions of that Regulation.

Indeed, that Regulation isn’t limited in scope only to providing electronic IFU instead of paper IFU.  Rather, along with that scenario, it also contains certain provisions applicable to all medical devices (excluding EU MDR Annex XVI devices) whose IFU are provided in both electronic and paper format.  Be sure not to err regarding that scope.  This is in alignment with the longstanding precedent established by the sunsetting Regulation (EU) 207/2012.

Also, remember to integrate your compliance approach with measures to meet the EU MDR’s Annex I.23.1 / IVDR’s Annex I.20.1 website provision (which has overlap with the eIFU’s website-related provisions).

Remember also that EU MDR Annex I.23.1(f) reminds us that instructions for use may be provided to the user in electronic format only to the extent, and only under the conditions, set out in the eIFU Regulation.

April 24, 2023 follow-up:

For example, I definitely consider IFU placed on a website to be eIFU. And so, excluding Annex XVI devices, my interpretation of the aforesaid Commission stance is, again, that any eIFU provided in addition to paper IFU must comply with the applicable provisions of Regulation (EU) 2021/2226.  But this needs to be done in remembrance that only certain aspects of 2021/2226 apply to the “in addition to” scenario.  Feel free to contact us for more specific assistance regarding your particular eIFU scenario.