Long-Awaited EU IVD Classification Guidance Just Published: Initial Reactions
Executive Summary
The European Commission has finally published detailed guidance on the EU IVDR’s classification rules. The IVDR’s completely new classification regime means guidance is urgently needed.
You may also be interested in...
Global Medtech Guidance Tracker: November 2020
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four guidance documents have been posted on the tracker since its last update.
Why IVD Industry Must Address Growing EU Urgency And What Factors Are At Play
It is just over 18 months until the full application of the IVD Regulation. The MDR may be the main focus of attention, but there is no less urgency when it comes to preparing for the IVDR. But the industry is dragging its feet.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.