Labeling eIFU Implementation Regulation Summary for EU MDR
It is beneficial for some medical devices to be provided with instructions for use in electronic form (eIFU) instead of in paper form as it helps to reduce the environmental burden, maintains or improves the level of safety, can be accessed readily in all union languages and reduces costs for the medical device industry. To meet this requirement, the European Commission on December 14th, 2021 issued an Implementing Regulation (EU) 2021/2226 with 11 Articles