Class III animal-derived dental bone graft material achieves MDR certification
A South Korean medical device manufacturer has achieved MDR certification for an animal-derived dental bone graft material classified as a Class III device. The certification followed conformity assessment by DNV as Notified Body #2460 under MDR Annex IX Chapters I, II and III.
The milestone highlights the increasing complexity of MDR certification activities, particularly for devices incorporating animal-derived materials, which are subject to additional regulatory scrutiny due to their biological origin.
The challenge
Class III devices containing animal-derived materials are among the most complex product categories under MDR. Manufacturers must demonstrate conformity through comprehensive assessment of quality management systems, technical documentation, clinical evidence, risk management and post-market activities.
The assessment
The conformity assessment was conducted by DNV under MDR Annex IX Chapters I, II and III. The assessment included evaluation of the manufacturer's quality management system alongside detailed review of technical and clinical documentation to verify conformity with applicable MDR requirements.
Given the complexity of Class III devices, the process required close collaboration between quality management, technical and clinical assessment disciplines to ensure a comprehensive and consistent evaluation.
Industry significance
As manufacturers continue adapting to the regulatory expectations introduced by MDR, notified bodies are increasingly assessing complex products involving advanced materials, novel technologies and higher-risk applications.
The certification of animal-derived Class III devices demonstrates the depth of evidence, documentation and regulatory oversight required to support conformity assessment under the current European regulatory framework.
For manufacturers operating in this environment, early preparation, strong quality systems and well-developed technical and clinical documentation remain critical to navigating MDR certification successfully.
