Search Tag: IVDR

IVDR Is Here, But Where Are the Notified Bodies?

2022 27 May

The In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) was passed by the European Union back in April 2017 to address concerns surrounding patient safety and transparency since an estimated 70% of clinical decisions revolve around in vitro diagnostic devices.  Major changes from the old regulation include greater third-party oversight required... Read more