January 25, 2022

[FEATURED] Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions

The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.

Do you like it?0
January 18, 2022

[FEATURED] EU Notified Bodies Warn Of Major Obstacles To MDR/IVDR Implementation

TEAM-NB, the EU notified body association, warns of disruption in device supply if critical action is not taken to ease the path to implementation. It says the many new medtech regulatory shifts, guidance documents and structures adopted in 2021 must be augmented.

Do you like it?0

Named the #1 Regulatory Services Company 2022 by Life Sciences Review

X