Medical devices utilizing animal tissue in the industry

Animal tissues and their derivatives are utilized within medical devices to provide performance characteristics that have been chosen for advantages over non-animal based materials.

The range and quantities of materials of animal origin in medical devices vary. These materials can comprise a major part of the device (e.g. bovine/porcine heart valves, bone substitutes for use in dental or orthopaedic applications, haemostatic devices), can be a product coating or impregnation (e.g. collagen, gelatin, heparin), or can be used in the device manufacturing process (e.g. tallow derivatives such as oleates and stearates, fetal calf serum, enzymes, culture media).

Commission Regulation 722/2012, effective from 29 August 2013, concerning active implantable medical devices and medical devices manufactured utilizing tissues of animal origin has been published in the Official Journal of the European Union. The Regulation replaces the existing requirements contained in Directive 2003/32/EC and clarifies the processes required for using tissues from TSE-susceptible animals in medical devices.

Suppliers of materials of animal origin can also apply to BSI for EN ISO 13485 certification which may provide a competitive advantage when seeking to do business with device manufacturers. Certification will include a review against relevant requirements of BS EN ISO 22442-1:2020 or BS EN ISO 22442-2:2020 and may be taken in to consideration by Notified Bodies during conformity assessments.

BSI is one of a few Notified Bodies designated to certify devices manufactured utilising materials of animal origin including those derived from Transmissible Spongiform Encephalopathy (TSE) susceptible species (TSE Susceptible Species are: bovine, caprine, deer, elk, feline, mink, ovine).

Our large in-house team of experts understands the challenges in gaining successful certification for your products. Our auditors are qualified to conduct assessments at slaughterhouse facilities, tissue processors and all the way through the manufacturing chain to the finished product.

Our full scope covers the entire spectrum of devices in combination with:

• Regulation 722/2012
• BS EN ISO 22442-1:2020 or BS EN ISO 22442-2:2020 and all other aspects related to your certification needs across a wide range of device technologies
• Sourcing and processing controls
• Inactivation and elimination of viruses and TSE agents
• Quality system assessments