Do you need to send human cells and tissue to a partner in Europe? Do you want to export these tissues from your laboratory in Europe to a laboratory in a third country or vice versa? To do this, it is necessary to know and follow the rules established by the European Commission. Keep reading to find out more!
The regulation of tissues and cells in Europe is implemented by the European Union Tissue and Cell Directives (EUTCD). The Directives establish common safety and quality standards for human tissues and cells throughout the EU.
All tissues are covered by these directives, except for certain types:
- Tissues or cells used as autologous grafts during the same surgical procedure.
- Blood and blood components.
- Organs or parts of organs when they are intended for the same use as the entire organ of the human body.
Some obligations must be respected. For example, it is mandatory to identify the origin of tissues or cells with the “Single European Code” (SEC). This code consists of:
- A donation identification sequence (SEC-DI), which identifies the organizations that produce and export cells and tissues;
- A product identification sequence (SEC-PI), which identifies the type of tissue and cell under consideration.
The SEC applies to all tissues and cells distributed for human application. When tissues or cells are transported from one laboratory to another, the identification sequence (SEQ-DI and SEC-PI) must at least be written in the sample documentation. It is the laboratory importing the product that is responsible for ensuring that the sample follows SEC guidelines.
The only medical uses not covered by this obligation are reproductive cells from partner donations, tissues and cells distributed directly for immediate transplantation to the recipient or tissues and cells imported into the EU in case of emergency.
In addition, SEC is not mandatory for Member States if the tissues and cells used for donation remain within the same institution. Of course, provided that the center is allowed to use human tissues.
Samples imported from non-EU countries must bear the Single European Code for distribution in the EU, unless they are imported directly to the place where a patient can benefit from them. According to the Directive, samples must be easily traceable from the donor to the recipient and vice versa.
Finally, laboratories in Member States receiving samples imported from non-EU countries should ensure that they meet quality and safety standards equivalent to those laid down in this Directive.
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