Angeliki Valsamidou

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EU Agreement on a General Approach on the Medical Devices Package

On October 5, 2015, after three years of continued discussions and negotiations on the modernization of EU medical devices and IVD rules, the Council of Ministers of the EU countries (“the Council”) agreed on a full General Approach on the review of the medical devices and IVD framework. The European Commission considers this as “a … Continue Reading

Update on the European Proposal for a Medical Devices Regulation

After almost two years of discussions and negotiations, the adoption of new EU medical device rules remains a challenging process that is not likely to be completed in 2014.  The recent European Parliament elections mean that new Members will need to familiarize themselves with the proposal and the issues.  Here we provide an update on … Continue Reading

Call for Expression of Interest to Participate in early dialogue between HTA bodies and healthcare product developers

A call for expression of interest addressed to healthcare product developers who would be interested in engaging in early dialogues (EDs) with Health Technology Assessment (HTA) bodies was launched in December 2013 and will stay open until October 2014.  The call concerns developers of both medicinal products and medical devices. The European Commission defines HTA … Continue Reading