Animal-Derived Materials in Your Medical Devices: From Exploring Requirements to Remediation. How to Approach This Complex Subject?

Do you recognise this situation?

Your medical device incorporates animal-derived materials. You are preparing a CE marking renewal, anticipating an audit, or integrating new team members who have never been trained on these specific requirements. Perhaps non-conformities have also been identified during an audit, and a remediation plan is needed.

In all cases, one common thread: the requirements applicable to animal-derived materials are complex, span multiple reference frameworks, and their impacts extend well beyond the technical documentation alone reaching into clinical evaluation, manufacturing and quality controls.

What was at stake

Animal-derived materials are subject to a specific regulatory framework: Regulation (EU) No 722/2012 and the EN ISO 22442 family of standards (parts 1, 2 and 3).

Their impacts are broader than often assumed:

• On the technical file and clinical evaluation: the relevance of using an animal-derived material compared to lower-risk alternatives must be demonstrated and documented. A choice that needs to be considered from the earliest stages of the project.
• On manufacturing: depending on the material concerned, specific validations are required: elimination and/or inactivation of viruses and TSE (Transmissible Spongiform Encephalopathy) agents.
• On competencies and controls. People involved in manufacturing and incoming quality controls must master these specific requirements.
• On the supply chain. Each link must be qualified and monitored against these requirements.

This is also a subject at the heart of the One Health approach: managing the risks associated with animal-derived materials sits at the interface between animal and human health — a dimension that enriches the analysis and enables a more complete understanding of the challenges involved.

What was done

As part of a remediation request following numerous non-conformities identified during an audit, I supported a company across all the requirements applicable to animal-derived materials in the form of a training and working day with the teams concerned, entirely tailored to the product and company context:

• Review of the requirements of Regulation (EU) No 722/2012, the EN ISO 22442 family of standards parts 1, 2 and 3, and other relevant reference frameworks to ensure a shared and up-to-date understanding of the applicable requirements.
• Key points of risk management for animal tissues with an analysis of the specific impacts for the product and the company’s context, including the justification for choosing an animal-derived material over available alternatives and the implications for clinical evaluation.
• Specific manufacturing requirements: validations required for the elimination and/or inactivation of viruses and TSE agents, competency expectations for the people involved, and incoming quality controls.
• Impacts on subcontractors in the supply chain identifying the requirements applicable to each link in the chain and the control points to put in place.
• Impact on internal and supplier audits: how to integrate these requirements into existing audit programmes.
• Impact on regulatory and scientific monitoring to maintain compliance over time as reference frameworks and available data evolve.

What changed

The teams gained a clear and operational understanding of the requirements applicable to their specific context. An action plan was defined to correct the identified non-conformities. And beyond the immediate remediation, the company had a solid foundation to manage this process in a compliant and autonomous way going forward.

→ Do you incorporate animal-derived materials into your medical devices and want to verify your compliance level or strengthen your practices? A One Health Compliance Technical Day allows you to explore the requirements applicable to your context and anticipate the impacts on your project in one day, with your team.

→ Have you identified non-conformities and need an operational action plan? A One Health Compliance Workshop combines a review of requirements and collaborative work on your situation to correct effectively and prevent recurrence.

References:

• Regulation (EU) No 722/2012 on medical devices manufactured utilising tissues of animal origin. Available at: http://data.europa.eu/eli/reg/2012/722/oj.
• EN ISO 22442 family of standards: parts 1, 2 and 3.

Sandra Dejean, PharmD – Founder of One Health Compliance

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