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Where And How eIFU Rules Will Apply Under The EU’s Medical Device Regulation

 
• By Amanda Maxwell

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.

Examine and study instructions, showed as a magnify glass.

The European Commission has published a new implementing regulation laying down rules regarding the use of electronic instructions for use (eIFU) in the context of the EU Medical Device Regulation (MDR). It will enter into force from 3January 2022 and replace earlier eIFU rules adopted in the context of the former medical device directives.

The possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to

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