The New EU In Vitro Diagnostic (IVD) Regulation: What You Need to Know

In May 2016, European Union (EU) institutions agreed to draft text for the In Vitro Diagnostic Device Regulation (IVDR) that will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC. The new regulation introduces significant changes for IVD manufacturers that currently hold a CE Mark or plan to market their products in Europe. To start getting ready, Oriel STAT A MATRIX has compiled a list of high-level compliance changes that will need to be considered. Updated IVDR Timing The […]

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