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Orphan IVD Devices: Team-NB Position Paper by s.sivakumar1891 is a document available to read on EtoBox.

What is Orphan IVD Devices: Team-NB Position Paper about?

The Team-NB Position Paper addresses the lack of specific provisions for orphan in-vitro diagnostic (IVD) medical devices in current EU regulations, emphasizing the need for a clear definition and assessment criteria for these devices. It proposes a definition for orphan IVDs based on prevalence and the absence of alternative treatment options, while also outlining considerations for performance evaluation and clinical evidence requirements. The document aims to guide manufacturers and regulatory bodies in

Author

s.sivakumar1891

Language

EN