How the MDD (medical device directives) review impacts clinical data and evaluation requirements
This article was originally published in Clinica
Executive Summary
Among the most extensive changes being made to the medical device directives are those concerning clinical data. In this article, Sarah Sorrel, president of MedPass International consultancy, looks at how these key changes in clinical data requirements may impact manufacturers in terms of clinical trials strategies, resources, timing, commitment and planning, and what this might mean in terms of competition with other markets and the development and funding of innovative products in the EU.
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