Module 16 2022

05/09/2022

What is a Notified Body?

• Private, independent testing or certification organisation • Provide conformity assessment service against the requirements of a Directive • Under the jurisdiction of their national Competent Authority

• Member States are not obliged to appoint a NB • A Member State may appoint any number of NBs

Historically a wide differences between NBs Size / Experience / Costs / Expertise / Interpretation

The Organisation for Professionals in Regulatory Affairs

3

What is Conformity Assessment ?

“Conformity assessment is the systematic examination of evidence generated and procedures undertaken by the manufacturer to determine that the device is safe and performs as intended”

Principles of Conformity Assessment -GHTF/SG1/N40:2006

The Organisation for Professionals in Regulatory Affairs

4