Revision of the In-Vitro Diagnostic regulatory framework

On 26 September 2012, the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices which will, once adopted by the European Parliament and by the Council, replace the existing three Medical Device Directives. 


When are the Medical Device Directives changing?


Both regulations are in the final stages of the legislative procedure and are expected to be finalized sometime in 2016, allowing them to come into effect by the end of 2016, or early 2017.



Changes to the way In Vitro Diagnostics are regulated in Europe

IVD Factsheet: for further information

The IVD Directive will soon be replaced by the IVD Regulation and this is a list of web links and documents that may be useful to address the regulations both now and in the future.