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The medical device investigator community is fragmented between technology sectors (orthopaedics, assisted living, cardiology, neuroscience, ophthalmology, diagnostics, etc.). It is also fragmented between countries as the previous legislative context resulted in low incentives for multinational trials in Europe. However the recent regulatory changes, with the enforcement in 2010 of the 2007/47/CE Directive, increasing the need for clinical evaluation, will foster the conduct of multinational trials, particularly leading to assessment of their efficacy and safety in view of the decision on pricing and reimbursement.

This is a challenge as medical devices SMEs often lack the capacity to act as a sponsor for multinational clinical trials, and also lack the methodological and clinical expertise. In addition, investigator-driven clinical trials are required to promote the evidence-based use of these procedures through comparison of treatment (or diagnostic) strategies. Creating a single, pan-European hub federating investigator networks in the medical device area will therefore contribute to bridge the gaps between countries and between technology sectors, and provide investigators required to design and conduct multinational trials in Europe.

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