Clinical evidence requirements of In vitro Diagnostic Devices in the future EU IVD Regulation
In September 26th 2012, the European Commission proposed a draft for an in vitro diagnostic Regulation in order to overcome flaws and divergences in interpretation of the current IVD Directive 98/79/EC and to further strengthen patient safety.
Since then this draft have been amended by the European Parliament in October 2013 and the European Council provided its approved revision on September 21st 2015.
Following the trilogue, on May 25th 2016, The Netherlands presidency of the Council and representatives of the European Parliament agreed on new rules for in vitro diagnostic medical devices.
This newsletter will present the new clinical/performance evaluation requirements, for IVD products and manufacturer, introduce by this new regulation.