eAF 1.25.0.0 version
Marketing authorisation holders and Applicants are informed that the mandatory use of the eAF 1.25.0.0 starts
on 1st November 2021. The main changes in this version of the forms relate to the implementation of the
Medical Device Regulation Art 2(1) of Regulation (EU) 2017/745, which came into force at the end of May.
