The Commission has adopted two sets of rules for human tissues and cells to protect patients in the EU by ensuring high quality and safety standards.
The first set of rules set out the technical requirements that will facilitate tracing of all tissues and cells between donor and recipient. This will happen through a so-called ‘Single European Code’ and a Commission-hosted IT-platform to ensure 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.
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 rules will ensure the safety of EU recipients in need of tissues and cells, regardless of the origin of the material.
For more information, click here on http://ec.europa.eu