Module 19 2021

24/05/2021

Review of technical documentation under IVDD

Annex II Most technical files reviewed by NB

Non-Annex II Few if any technical files reviewed by NB

The Organisation for Professionals in Regulatory Affairs

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

8

4