REG-91 version 1

Guideline For Notified Bodies Applying For A Scientific Opinion (Consultation) On Ancillary Medicinal Substance That Is An Integral Part Of A Medical Device  

This guideline supersedes guideline REG-91 with the effect from 1st May, 2017


The Gudeline 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. 268/2014 Coll.

The Guideline is for recommendation.

REG-91_version1.pdf, file type pdf, (360.9 kB)