Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Guidance on the format of the Medicinal Dossier

MEDDEV 2.1/3 rev 3 EMA dossier requirements Eudralex Notice to Applicants Volume 2B

Copyright © 2022 BSI. All rights reserved

33

Public

Focus of this Session

Staked-needle Pre-filled Syringe

 .  .  .

Single integral

Intended exclusively for use in the given combination

Non-reusable

Copyright © 2022 BSI. All rights reserved

34

17