EIFU - Instructions for use

GalitSa

Starting to get Involved
We are develop produce a Class IIa medical device.
According to MDR regulations, can we use an electronic Instructions for Use (eIFU) instead of a printed IFU?
We will include a QR code that leads users to the eIFU on box and product.
 

Cybel

Involved In Discussions
Hi, you should take a look to the COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices: manufacturers may provide instructions for use in electronic form instead of in paper form only in some cases and under specific conditions.
 
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