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MedTech Europe Calls For EU To Amend Regulation To Allow For eIFU For Low-Risk Devices

 
• By Amanda Maxwell

The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.

Cropped image of male technician using computer in medical laboratory

EU industry association MedTech Europe is calling on the European Commission and EU member states to amend the Implementing Regulation (EU) 2021/2226 to allow for an expanded use of electronic format instructions for use (IFU), instead of paper, for all medical devices used by professionals.

Despite having been only recently adopted, Regulation 2021/2226, the European Commission Implementing Regulation on eIFU in the context of the Medical Device Regulation, isalready outdated, the association considers.

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