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Tissuevigilance definitions

Member states shall ensure that there is a system in place to report, investigate, register and transmit information about:


Serious adverse events and reactions which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, storage and distribution of tissues and cells, as well as any serious adverse reaction observed during or after clinical application which may be linked to the quality and safety of tissues and cells.

Directive 2004/23/EC

Technical requirements I: 2006/23/EC

Technical requirements II: 2006/86/EC