CE Marking Renewal for an Animal-Derived Implantable Device Marketed for Over 20 Years

Context

A French SME needed to renew the CE marking of a Class III animal-derived implantable device that had been on the market for over 20 years against a backdrop of significantly strengthened European regulatory requirements (MDR) and applicable standards for animal-derived materials (ISO 22442).

The challenge

The notified body raised numerous questions about the animal tissues used in the device’s composition. Responding within very tight deadlines was essential to avoid compromising the product’s availability on the market. An additional difficulty: the absence of formalised documentation on the design choices of a product that had been on the market for over two decades.

The One Health Compliance solution

• Deployment of a reverse engineering approach to reconstruct the design history and formalise risk analyses.
• Drawing on specific expertise in animal-derived materials (ISO 22442, Regulation (EU) N° 722/2012) and collaboration with the biomaterial supplier to recover key missing data.
• Assembly of a complete file including specific risk management, biomaterial traceability and in-depth clinical benefit review.

The result

• Favourable opinion from the notified body.
• CE marking renewed.
• Continuity of commercialisation ensured without interruption.

✓ File accepted by the notified body ✓ CE marking renewed ✓ No interruption to commercialisation

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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