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Archives for IVDD

The European Commission released its proposal for the revision of the EU Medical Devices (MDD) and In Vitro Diagnostics Directives (IVDD) in September 2012. The European Parliament weighed in the file, voting on its final report in a plenary session last October. And in December we heard reps from the 28 EU health ministries voice… » read more

Posted by MedTech Europe

Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for in vitro diagnostics (IVD) rather than a bureaucratic quagmire.  The sweeping changes being made to risk classification will be complex and time-consuming.  The lessons learned from similar overhauls in other markets show… » read more

Posted by MedTech Europe

A surprising few things have happened lately. Firstly, the weather in Belgium CAN be nice and pleasing to a Franco-Italian such as myself. Secondly, the ENVI Committee vote that was scheduled to take place on 10 July was postponed to 18 September for both the Medical Devices and In Vitro Diagnostics Directives. If I did… » read more

Posted by MedTech Europe

World Health Day approaching us on April 7th is meant to raise awareness on the endless host of hurdles that undermines our health and therefore, our quality of life. Public health is about making sure that the external factors that determine our health are governed by policies that have people’s well-being at the very heart of… » read more

Posted by MedTech Europe

By now most of you will have noticed that we have launched our “Don’t Lose the 3”-campaign. (If you haven’t, watch the 1-minute video and patient stories here). The basic message of the campaign is that, thanks to our decentralised approval system for medical devices in Europe, Europeans have access to life-saving and life-enhancing technologies… » read more

Posted by MedTech Europe