Europe: Requirements of Medical Device eLabeling & eIFU Under the EU MDR

ARQon
Dec 17, 2021
1 min read

The European Union has allowed the use of electronic instruction for use (IFU) since March 2013 and provides Regulation 207. Recently in September 2021, EU has drafted an update to this regulation to align with few sections of EU MDR. This updated version is expected to be published soon. No. Article 3 of the EU’s eIFU regulation mentions that they can only be used for the following types of devices:

Devices and accessories for professionals use only
Software (paper option not required)
Devices with built-in screen displays (paper option never required)
Fixed installed medical devices (paper option never required if device has screen)
Implantable devices (paper option not required)

Also, it is good to always remember that based on Annex I, Chapter III, 23.1(d) of the EU MDR, Class I and II devices do not require IFU at all if they can be safely used without instructions. There are a several factors to be taken into account when switching to eIFU which are: