Medical devices utilizing animal tissue

Medical devices utilizing animal tissueManufacturers of medical devices that use tissues of animal origin should be aware that, depending on the nature of the animal tissue or derivative, may need to consider Regulation 722/2012.

BSI recognises that the requirements for medical device manufacturers who utilize tissues of animal origin can be burdensome. We have the expertise, knowledge and proven capability to guide you through this difficult process.

What are medical devices that utilize materials of animal origin?

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).

European Commission Regulation 722/2012 and Directive 2003/32/EC

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 - EN ISO 13485 and EN ISO 22442

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 EN ISO 22442 and may be taken in to consideration by Notified Bodies during conformity assessments.

Why choose BSI for certifying your devices that utilize animal tissue?

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.

Experience of starting materials and derivatives

 

 

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

  • Regulation 722/2012
  • EN ISO 22442 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

 

Device technologies

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