Ready for the EU Tissue and Cell Labeling Rule?
by Craig Hodgson, on March 31, 2017
As of April 29, 2017, all organizations within the European Union (EU)—as well as companies that do business in the EU—must have a single European code (SEC) or label on all donated tissue and cells used for human application. Introduced by the European Commission in 2015, and adopted by Member States in 2016, 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 requirements in the US and internationally, failure to comply with the EU SEC can result in significant fines as well as the holding or confiscation of materials that are in violation of the code, which can pose a significant health risk to patients waiting for donated tissue and cells.
Where are you in terms of compliance with this impending regulation? Do you know if you’re exempt from some of the requirements? How can you leverage your existing UDI barcode labeling processes to adapt to this new EU medical device directive? Get the answers to these and other questions in this brand new Q&A report “EU Labeling of Human Tissue and Cells: How Will You Sustain Compliance?”
Featuring insight from two leading experts on medical device labeling and regulations, this helpful, interview-style document is a must-read for Quality, Compliance, IT and Supply Chain professionals alike. Both Jay Crowley from USDM Life Sciences and Guenther Martin from Loftware bring decades of experience in working with companies to understand evolving industry requirements and apply best practices to not just achieve compliance but optimize overall operations.
Even if you’re already prepared for the April deadline—or think you are—we encourage you to download the report for some fresh perspectives that could benefit your organization in the long run.