MedTech Europe Calls For EU To Amend Regulation To Allow For eIFU For Low-Risk Devices
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.
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Large volumes of paper IFU accompanying medical devices are harming the environment, say German medtech organizations. Armed with national survey data, they want to raise the issue of expanding eIFU at European and national levels.
Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.
Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.