Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

7

Notified body expertise under IVDD

Annex II NB’s generally familiar with these products

Non-Annex II NB’s mostly unfamiliar with these products which are self certified by the manufacturer

The Organisation for Professionals in Regulatory Affairs

7

8

Notified bodies under IVDD = 19

‘

The Organisation for Professionals in Regulatory Affairs

8