H-1051 Budapest, Zrínyi u. 3.

Tel.: (1) 8869-300, E-mail: ogyei@ogyei.gov.hu

Mail: 1372 P.O. Box: 450.


eAF version

Marketing authorisation holders and Applicants are informed that the mandatory use of the eAF 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.

Last updated: 2021.10.19 12:00