Human tissue devices may fall temporarily into pharma arena
This article was originally published in Clinica
Medical devices and diagnostics containing viable human tissue products could be subject to European Union pharmaceutical requirements ahead of being regulated by particular human tissue requirements. A clause has been included in the proposal for the modification of the Directive on the community code (to consolidate and codify human use pharmaceutical directives), which if it remains unchanged as it moves through the EU legislative process, will encompass human tissue devices.
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