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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

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Caveat Emptor, or ‘Buyer Beware’, is a commercial rule favouring the seller, now largely extinct due to modern consumer legislation. But the European Parliament’s ENVI Committee, in its amendment on the reprocessing of single-use medical devices, has unwittingly slipped something similar back in again. Given the complex and highly technical nature of the Medical Devices… » read more

Posted by MedTech Europe

Europe’s medical device industry has always agreed that Europe’s regulatory system for devices needs to be improved and has put forward various proposals to achieve this. In the wake of a case of fraud like the PIP breast implant incident, it is clear that we need a safer system that makes sure Europe’s patients continue… » 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