Implementation deadlines for the EU In Vitro Diagnostic Medical Device Regulation further postponed

Extending the transitional periods for implementation

A considerable number of in vitro diagnostic medical devices (IVDs) currently on the European market do not yet comply with the In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). The deadlines for IVDs to comply with the new requirements were looming and causing significant concern for the industry, the pharmaceutical sector and healthcare professionals. Recognising the pressures of recertification and the distinct possibility of IVDs being unavailable for clinical use, the European Commission has proposed further extensions to the IVDR transitional periods.

Read the full article here