Module 16 2022

05/09/2022

Notified Body activities in the Conformity Assessment

• Evaluate manufacturer’s compliance to legislation • Issue certification (EC) to permit CE marking of a device • The Company chooses its NB body: provided they are designated in that device area. • NBs listed per Regulation and Scope https://ec.europa.eu/growth/tools databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 • NB may sub-contract some assessment activities but retains final Certificate decision responsibility

• Scrutiny and involvement increases with higher classification • The NB number appears on labelling (Where NB involved)

The Organisation for Professionals in Regulatory Affairs

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Notified Body Assessment

The Organisation for Professionals in Regulatory Affairs

6