The new Medical Device Regulations (MDRs) became enforceable in May 2022. This significant regulatory shift requires that all new devices intended for the European market must demonstrate compliance with ISO 10993, irrespective of whether they have been on the market for several years. This regulation aims to ensure the highest standards of safety and effectiveness for medical devices in Europe. The ISO 10993 standard pertains to the biological evaluation of medical devices, focusing on their interaction with biological systems.
This presentation will walk through a real-life example of bringing a device that has been on the market in Europe into compliance with ISO 10993 and the new MDRs. This involves a comprehensive evaluation of the device’s materials, manufacturing processes, and potential biological risks. We will explore the necessary steps for testing and documentation required to meet these stringent regulations.
Viewers will gain insights into the practical challenges and solutions encountered during the compliance process. This includes a detailed discussion on risk management, testing strategies, and the importance of thorough documentation. By the end of this presentation, participants will have a clear understanding of how to navigate the complex landscape of MDR compliance, ensuring their devices can continue to be marketed in Europe without interruption. This knowledge is crucial for manufacturers aiming to maintain market access and uphold the highest standards of patient safety and product quality.