Understanding Europe’s In Vitro Diagnostic Medical Devices Regulation

The European Commission (EC) released the initial draft of the proposed European Regulations for In Vitro Diagnostics (IVDs) in 2012. It was strenuously negotiated by the European Council, the European Parliament, and the EC. The result of the deliberations was a "Consolidated Compromise text." The Regulation was published in 2017 as the In Vitro Diagnostic Medical Devices Regulation (EU) No. 2017/7461 with a date of application (DoA) of May 26, 2022, in the Official Journal of the European Union (OJEU). In this whitepaper, we discuss how the Medical Device Coordination Group (MDCG) has released numerous guidance documents as well as a few implementing laws following the publication of the MDR and IVDR.