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REG-91 version 3

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.

REG-91_version3.pdf, file type pdf, (316.09 kB)