Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in accordance with ISO 22442 for receipt of the CE Mark and subsequent EU commercialisation. This article discusses important regulatory animal sourcing requirements associated with medical devices that cover these biological risks. These requirements include risk management, animal health controls, quality system elements, and demonstration of safety related to potential transmissible pathogens. The necessary information needs to be presented in the form of reports, risk analyses, and other documentation.