EU Prepping for New Labeling of Human Tissue and Cells

by Laura Johnson, on October 27, 2016

2011-04-19171613_^_u-flag.jpgMember states of the European Union (EU) have just a few days left to adopt standardized labeling for donor tissue and cells. October 29th is the deadline for EU countries to sign into legislation the requirement of a Single European Code (SEC) to be applied to all donated tissue and cells used for human application. Introduced by the European Commission last year, the standardized code is designed to ensure the proper identification and traceability of these materials—from the donor to the recipient and vice versa.

Much like UDI labeling in the US, the SEC provides key data and properties of tissues and cells, including a unique ID number, source, product code, split number, and expiration date. The code is accessible through a Commission-hosted, publicly accessible IT platform and allows users to retrieve relevant information on the tissue and cell product itself as well as on the associated tissue establishment, its authorization, activities, and contact details.

There are a few exclusions and exceptions to the coding requirements, but for the most part the SEC must be applied to all tissue and cells distributed to hospitals and providers for human application. In those situations where tissue and cells are released for circulation to advanced therapy medicinal product manufacturers or other third parties, only the Donation Identification Sequence (DIS) part of the SEC needs be applied to accompanying documentation.

Once members of the EU adopt the SEC directive as part of their legislation, the next key date is April 29, 2017, when they (and the organizations within their country impacted by the rule) must apply the SEC requirements on all newly donated tissue and cells. Any tissue and cells already in storage are exempted from the labeling as long as full traceability is ensured by other approved methods.

The next several months will be interesting to see how EU organizations are dealing with the new labeling requirement. At Loftware, we’ve been in discussions with a few global organizations affected by the rule. It's no small task to accommodate this change as companies must select, configure, implement, and validate their labeling process, ideally several weeks prior to the deadline to prepare existing inventory. Fortunately, if they have an Enterprise Labeling Solution, they're already ahead of the game.  

Because change is constant in the medical device industry, it’s critical that manufacturers, distributors, and providers alike take a holistic, standardized view of labeling and tie it into the their existing business processes. This not only improves accuracy and creates more efficiencies across the extended supply chain, it also makes adapting to new customer and regulatory requirements that much easier and strategic.

Topics:Medical DevicesRegulatory