Module 18 2021

05/02/2021

Role of the Notified Body

• NB fees vary depending on service required but are publicly available • Cost per Hour / Day. • Quality of submission will affect overall cost • NANDO (New Approach Notified and Designated Organizations) Information System provides a list of designated NBs https://ec.europa.eu/growth/tools- databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

The Organisation for Professionals in Regulatory Affairs

9

The Organisation for Professionals in Regulatory Affairs

10

5