The European Commission (EC) opened a four-week consultation on draft legislation allowing electronic Instructions for Use (eIFU) for medical devices used by professional users. Here’s what medical device manufacturers need to know about the proposed legislation.
Implementing Regulation 2021/2226 was intended to generally continue to advance Regulation 207/2012 on eIFU as devices (Article 3) that could be supplied with eIFUs were the same. Only a limited number of devices were considered within the scope of the legislation.
Healthcare professionals prefer eIFUs
In August-October 2024, the EC surveyed healthcare professionals about their preferences for eIFUs. The results: a “clear preference” for eIFUs (Recital 2 draft legislation).
EU Opens Consultation on Draft Legislation for Electronic IFUs | Emergo by UL
EU Opens Consultation on Draft Legislation for Electronic IFUs
Here’s what medical device manufacturers need to know about the proposed legislation that the European Commission (EC) opened allowing electronic Instructions for Use (eIFU) for medical devices used by professional users.
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