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My company stores and uses human cellular material for the mandatory assessment of diagnostic devices - does the Human Tissue Act 2004 affect our work?

Date published: December 2016

Schedule 1 of the Human Tissue Act 2004 (the Act) sets out ‘performance assessment’ as a ‘scheduled purpose’.

An HTA licence is required if the human cellular material (‘relevant material’) to be stored for performance assessment has been removed from the deceased.

My company stores and uses human cellular material for the mandatory assessment of diagnostic devices - does the Human Tissue Act 2004 affect our work?

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