Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Class 7: Class B

• Controls without a quantitative or qualitative value

The Organisation for Professionals in Regulatory Affairs

11

MDCG Guidance

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_md cg_2020_guidance_classification_ivd-md_en.pdf

The Organisation for Professionals in Regulatory Affairs

12