New EU rules on human tissues and cells increase patient safety

Apr 10, 2015

The Commission has adopted two sets of rules for human tissues and cells to protect patients in the EU through ensuring high quality and safety standards.

  • The first sets out technical requirements that facilitate tracing of all tissues and cells from donor to recipient, and vice versa. This will happen through a so-called ‘Single European Code’ and Commission hosted IT-platform ensuring uniform labelling of all tissues and cells distributed in the EU. In the case of a safety alert, this label will ensure that all recipients who received material from the same donor can be traced and treated as needed. It will also allow for unused tissues or cells to be discarded.

Commission Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells

  • The second directive covers imports and sets out procedures for ensuring that tissues and cells imported from third countries meet the same safety and quality standards as those procured, processed and distributed in the EU. These implementing rules will ensure safety for EU recipients in need of these tissues and cells, no matter their origin.

Commission Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells