This presentation will provide an in-depth overview of biocompatibility in compliance with the new Medical Device Regulations (MDR). The key focus will be on highlighting the significant differences between previous approaches for CE marking and the current requirements under the MDR. The new regulations introduce more stringent requirements for demonstrating the biological safety of medical devices.
Attendees will gain valuable insights into the specific biocompatibility requirements outlined in the MDR, including the expanded scope of biological evaluation. The presentation will emphasize the importance of thorough documentation and risk assessment, guiding manufacturers through the transition from the old regulations to the new framework.
Guidance will be provided to establish a roadmap to compliance, ensuring that all necessary steps are taken to meet the new standards. This includes understanding the critical aspects of the MDR related to biocompatibility, such as the need for comprehensive biological evaluations and the integration of risk management throughout the product lifecycle.
By attending this presentation, viewers will gain a clear understanding of the new biocompatibility requirements under the MDR. They will learn how to navigate the transition from the previous regulations to the new ones, ensuring that their medical devices continue to meet CE marking standards and maintain market access. This comprehensive overview is essential for manufacturers aiming to comply with the MDR and uphold the highest standards of biological safety for their products.