View Cart  

EC Proposes Risk-Based Classification System for IVD Medical Devices

A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could place new requirements on the majority of current Class A IVDs by bumping them up to Class B.

To View This Article:


Subscribe To International Medical Device Regulatory Monitor

Buy This Article Now

Add this article to your cart for $40.00