IVDR

Confronting the EU in vitro diagnostic regulation (EU IVDR) – Lift the fog!

The EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) The EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) took effect on 26 May 2017, and a transitional period of 5 years is in force till 26 May 2022. The IVDR replaces the current EU In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EC) to ensure a higher level […]