Regulatory Support for Medical Devices Using Animal Tissue

Expertise in ISO 22442

Materials of animal origin have unique properties and can bring significant clinical benefits for patients. Device manufacturers that utilize tissue of animal origin in their devices face additional regulatory burdens in some markets to address the risk of transmission of disease from animals (zoonosis). International standards ISO 22442 Parts (1-3) provide requirements for risk management as well as the sourcing and processing of materials.  The ISO standard is applicable to all medical devices that utilize animal tissue during the manufacturing process even if they are not present in the finished medical device. The standard applies to all animals (not just mammals) including birds and marine animals such as fish, shellfish, and coral.

EU and US FDA Compliance Strategy

In Europe medical devices manufactured utilizing tissue or cells of human or animal origin or their derivatives are considered to be Class III devices under Rule 18 unless they contact intact skin only. Manufacturers will need to ensure they comply with GSPR 13.2 and provide additional information on the animal material in their technical documentation. In addition Commission Regulation 722/2012 applies to tissues originating from Transmissible Spongiform Encephalopathies (TSE) susceptible species (e.g. bovine materials).

In the USA, the FDA developed guidance for medical devices containing materials derived from animal sources. In addition ISO 22442 is an FDA consensus standard (Part 1 has partial recognition; Parts 2 and 3 have full recognition).

We can assist with the strategy for all variations of products in this space including:

• Live cell and tissue products
• Cell therapies
• Decellularized products
• Tissue device combination therapies

US and EU Regulatory Expertise on Staff

NAMSA has medical device regulatory consultants with extensive experience in devices that utilize tissue of animal origin including experts who have previously served as Notified Body reviewers of high-risk medical devices including those containing animal tissue. NAMSA can provide a comprehensive range of services in this area including:

• Strategic advice on the use of animal materials
• Gap assessments and preparation of technical documentation in compliance with the requirements of the MDR, Regulation 722/2012, and ISO 22442
• Literature reviews and risk assessments to support TSE viral and inactivation
• Viral inactivation studies in accordance with ISO 22442-3 and regulatory expectations
• Pre- and post-market assessment of data on current zoonoses and zoonotic risk associated with the animal material
• Review and input on quality system processes for traceability, supplier controls, and training
• Review of animal tissue supplier documentation
• Animal tissue specific audits
• Clinical strategy and preparation of documented justifications for the use of the animal material
• Notified Body Audit support
• Training on the requirements of  ISO 22442 and Regulation 722/2012
• Preclinical and clinical testing strategies and study design
• US FDA presubmission meeting and interaction support
• Preclinical and clinical testing strategies and study design
• US FDA presubmission meeting and interaction support