Guideline for notified bodies applying for a scientific opinion (consultation) on ancillary medicinal substance that is an integral part of medical device
This guideline supersedes guideline REG-91 version 2 with the effect from 1st February, 2024
The Guideline is issued on the basis and in accordance with the provision of Section 13 paragraph 2, letter a), point 5 of Act no. 378/2007 Coll. and Act No. 375/2022 Coll.
The Guideline is for recommendation.
cz