Europe – European IVDR application partially postponed

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.

From IVDD to IVDR

Plans to replace the European In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) with the IVDR have been set since 2017. The IVDR initial date of application was planned for May 26, 2022…