Which ever market that you sell, you have to abide to the legal regulatory requirements.
Labelling requirements are different between USA and EU/Union and need to be considered as outlined. The MDR Annex I contains a lot of detail for labelling.
As the other participants have noted, not all medical devices are allowed to have e-IFU which is utlined in e-IFU Regulation 2023/226.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2226&qid=1713334553403
EU states they have Green Deal Industrial Plan etc.
Why though do they keep the use of e-IFU restricted to specific devices?
https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal/green-deal-industrial-plan_en
https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/european-green-deal/delivering-european-green-deal_en
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Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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Original Message:
Sent: 15-Apr-2024 05:01
From: Kati Marttinen
Subject: Anonymous question on IFUs
Dear RAPS community,
After MDR transfer the IFU usually changes a lot. We do not always opt for a new 510(k). Instead, for deliveries to the US, we plan to remove the CE IFU from the box and replace it with US IFU. Is this still compliant with the MDR, and towards FDA, as the device label carries a CE mark? To note, for logistic reasons we cannot create double items (REF/UDI) for separate markets.
If we choose eIFU for USA, does FDA require a symbol for eIFU in the label or carton box? We do not use the actual eIFU per Regulation 2021/2226, so we cannot use the ISO 15223 symbol on the label.
Thank you for all your comments!