Ronald Boumans, Emergo
Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20.
Following these votes, the MDR and IVDR are expected to be formally published in late April or early May. This means that the Regulations will enter into power in late May or early June of this year, as previously anticipated by Emergo consultants in The Hague.
Accordingly, the MDR will become applicable in three years (2020), while the IVDR will become applicable in five years (2022).
Based on Emergo’s initial analysis, there are few changes between the final versions of the Regulations and their draft versions published in 2016. However, some of these changes may significantly impact certain medical devices or economic operators in Europe. Over the next few months, we will analyze the MDR and IVR in depth, and publish pertinent information for industry participants affected by these new Regulations.
The new Medical Device Regulation adopted by the EU, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.