How to handle MDR (EU) 2021/2226 Article 5.3 and 5.4 requirements for eIFU?

We had similar questions during our technical file review. For Article 5(3), we put an SOP in place to ensure that when a request for a paper IFU comes in, we can deliver it within 7 days. Our SOP is pretty basic and mentions using an international express shipping service, but we haven't validated the process yet. During a technical file review, that seemed acceptable, but for an audit, I could imagine the notified body might want to see some evidence—maybe a test shipment to one country or proof of delivery within 7 days.

For Article 5(4), it really depends on your device's risk assessment. In our case, we determined that there are no foreseeable medical emergency situations, so we indicated in our gap assessment that 5(4) is not applicable. We didn't mention this explicitly on the label or IFU, just documented the rationale internally.

Notified bodies are required by Article 8 of EU 2021/2226 to review compliance with Articles 4 to 7 during conformity assessment, so we're planning to validate our process further for future audits.