REG-91 version 2

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 1 with the effect from 27th May, 2021


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. 89/2021 Coll.

The Guideline is for recommendation.

REG-91_version_2.pdf, file type pdf, (290.79 kB)