Medtech Insight

How Notified Bodies And Manufacturers Are Attempting To Navigate Uncertainty Under The IVDR

07 Jul 2023

There are still several missing key elements needed for the implementation of the EU’s IVD Regulation. Three key experts focused on how to move forward, particularly with the highest risk, class D, IVDs.

Labyrinth — Navigating The Way Through To IVDR Certification Can Still Be Tricky • Source: SC

When it comes to compliance with the IVD Regulation, as updated by the recent amending regulation, the biggest challenges relate to the highest risk, class D, IVDs.

Class D IVDs need meet the IVDR’s requirements by May 26, 2025, the first of the new deadlines created in...