New Regulation Significantly Expands eIFU Usage Scope

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.

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• Source: Shutterstock

The eIFU Amending Regulation has now been published in the Official Journal of the EU, allowing a broader range of use of electronic instructions for use (eIFU) with medical technology that comes under the scope of the EU’s Medical Device Regulation.

The document enters into force as of July 16.

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