Ensuring compliance with the Medical Device Regulation (MDR) requires a thorough evaluation of medical devices for the presence of carcinogenic, mutagenic, or reproductive toxicants (CMRs) at levels exceeding 0.1%. This presentation will outline a comprehensive strategy to assess whether medical devices contain CMRs, thereby meeting the requirements of MDR 10.4.
In instances where supplier information is unavailable, extractables chemistry testing becomes a critical tool for evaluating biocompatibility. This presentation will explain how data obtained from extractables testing can be utilized to demonstrate that device materials are free from CMRs. This approach provides a reliable means of compliance when direct supplier data cannot be accessed.
Participants will learn the step-by-step process for conducting this evaluation, including the identification and quantification of potential CMRs in device materials. The presentation will cover best practices for setting up and executing extractables chemistry tests, ensuring accurate and reliable results.
The strategy presented will also address how to interpret the data obtained from these tests and how to document findings to support regulatory submissions. By effectively leveraging extractables chemistry data, manufacturers can confidently attest to the absence of CMRs in their medical devices, ensuring compliance with MDR requirements.
Attendees will gain a clear understanding of the regulatory expectations and the practical steps needed to meet them. This knowledge is essential for maintaining the safety and regulatory compliance of medical devices in the European market.