Commissioner Says EU MDR/IVDR Implementation 'On Track,' But Fails To Convince Parliament
Elżbieta Bieńkowska, a European Commissioner, is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.
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Medtech stakeholders were reminded recently at the UK's largest regulatory forum that even those willing to make the best of Brexit are still working in the dark. The lack of useful government outreach is frustrating most efforts to secure business continuity. And that is without factoring in the huge regulatory changes that the EU's twin medical device regulations – the MDR and IVDR – will bring.
There were multiple investigative journalists with experience reporting on the "Paradise Papers," at the latest medtech regulatory conference in Brussels – but they gave nothing away about the medtech story they are pursuing.
Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.