How to Send Human Cells and Tissue to a Lab in Europe

Are you looking up how to send your human tissue sample from Germany to your colleagues in France? Or else, from the EU to a non-EU country?

When you are working on human tissues and cells in your lab, you may sometimes need to send samples to your partners in other labs. In that case, you need to know what the rules are to do it the right way.

The increased use of tissues and cells for human research has been calling for the right terminology and rules. The European Commission sets out rules on how to import or export tissues and cells. Let’s now see these rules in details so you know what to do with this tissue sample of yours.

The EU tissue and cells Directives set the rule across Europe

The European Union Tissue and Cells Directives

The regulation of tissues and cells across Europe are implemented by the European Union Tissue and Cells Directives ( EUTCD). The Directives set out a common safety and quality standards for human tissues and cells across the EU.

The EUTCD is made up of the parent Directive and two technical directives. The first provides the framework legislation and the technical ones provide the detailed requirements of the EUTCD.

The Directives include the regulation of procurement, testing, processing, storage as well as distribution and import/export.

What are the tissues and cells targeted?

Well, every tissue and cells excepted certain types, such as:

• Tissues or cells used as an autologous graft when it is during the same surgical procedure.
• Blood and blood components.
• Organs or parts of organs when it is for the same purpose as the entire organ in the human body.

The origin of the tissue or cells should be identified with the “Single European Code”

Since April 29th, 2017, EU member states whose labs work with tissue and cells have the obligation to follow the “ Single European Code” (SEC). It applies to the samples distributed in the EU, among other things for clinical application.

If you have detailed questions for using human cell lines, you can look at the Directives we talked about earlier. There, you will find all obligations related to labs working on human tissues.

It is interesting to know that a certain number of product coding systems already existed in the EU before 2017. This is why two organizations ( The international criminal court bar association and Eurocode) are allowed to maintain and use their codes as part of the SEC.

What is the SEC European code?

The SEC identifies the origin and type of tissue or cell. As the European Commission explains in the Questions and Answers about the SEC, the code consists of a donation identification sequence (SEC-DI) and a product identification sequence (SEC-PI).

What are SEC-DI and SEC-PI exactly?

The SEC-DI is the identifier for the organizations that produce and export the cells and tissue.

As you can see below, the SEC-DI consists of an ISO country code and the Tissue Establishment (TE) number. The TE is a number given to each lab producing cell lines which are established by the EU Tissue Establishment Compendium.

The “unique donation number” is attributed to a specific donation of tissues and cell-line. It can be allocated in different ways depending on each Member State (i.e. local allocation by the TE, central allocation by a national body/system, etc.).

Now the SEC-PI, it is the identifier for the type of tissue and cell in question.

There are three things to know for the SEC-PI. The first is the product code which identifies the type of tissue and cell. It indicates the coding system used (“E” for the EUTC, “B” for Eurocode) and the product number in this coding system.

The second is the split number which identifies tissues and cells when they have the same donation number because they come from samples from the same institution.

The last one is the expiry date by which the sample can be applied.

So, now you know how to identify the tissue or cell sample you have. But what happens if you need to send some sample away to a colleague in another EU country?

The lab importing the tissue is responsible to comply with the regulation.

Essentially, the SEC applies to all tissues and cells distributed for human application. When tissue or cells are transported from a lab to another, the identification sequence (SEQ-DI and SEC-PI) should at least be written in the accompanying sample documentation.

Who should be careful as to whether the sample follows the SEC or not? Well, the lab importing the sample is responsible for the application of the SEC on the product. It is also responsible for the proper accompanying documentation (double coding/labeling with the original code and the SEC).

Some medical use of tissue is allowed to be imported without the code. But there is only a few, such as reproductive cells from partner donation, tissues, and cells distributed directly for immediate transplantation to the recipient or tissues and cells imported into the EU in case of emergency.

Also, for EU member states, SEC isn’t mandatory when tissues and cells used for donation remain within the same center. It covers the transportation of a sample when it occurs only within the same institution. Of course, provided that the center is authorized to use human tissues.

Now you know your sample has to follow the SEC to be sent in another EU country. But, what if you are from a non-EU country and you want to send your sample to your colleague inside the EU?

Imported samples from non-EU countries should also be labeled with the “Single European Code” for distribution in the EU

The tissues and cells imported from non-EU countries should follow the same code unless they are imported directly to the place where a patient can benefit from it.

Member states have a role in ensuring that all imports of tissues and cells from non-EU countries are done by accredited, authorized or licensed organizations.

According to the Directive, the sample should easily be traced from the donor to the recipient and vice versa.

Also, labs from member states that receive imported samples from non-EU countries should ensure that they meet quality and safety standards that are equivalent to the ones laid down in this Directive.

Now that you have read this article you are ready to prepare for human cells import or export. You will be able to send your sample to your colleagues and work partners. Talking about partners, don’t hesitate to check out our database at Scientist to find some, working on human tissue and cells, or else.