The new Medical Devices Regulation (2017/745/EU) (MDR) aligns EU legislation with the latest technical advances, changes in medical science, and progress in lawmaking. This updated regulation brings significant changes that impact manufacturers of reusable medical devices. This webinar will provide a comprehensive overview of the necessary testing and documentation required to comply with MDR before the approaching deadline.
Participants will gain an understanding of the key updates introduced by the MDR and their implications for reusable medical device manufacturers. The session will cover the specific requirements that must be met to ensure compliance, including the enhanced focus on safety and performance standards. Viewers will learn about the extensive testing protocols that need to be implemented, such as biocompatibility testing, cleaning validation, and sterilization validation. Each of these tests is critical for demonstrating that reusable medical devices can be safely reprocessed and reused without compromising patient safety.
The webinar will also detail the documentation requirements under the new MDR. Manufacturers will learn about the technical documentation that needs to be compiled, including detailed risk management files, clinical evaluation reports, and post-market surveillance plans. These documents are essential for proving that the devices meet the stringent requirements set forth by the MDR. Additionally, the session will highlight the importance of maintaining up-to-date and comprehensive records to facilitate regulatory reviews and audits.
By attending this webinar, participants will be equipped with the knowledge and tools to navigate the complexities of the MDR compliance process. They will understand the critical steps that need to be taken to ensure their reusable medical devices are in full compliance with the new regulations. This session is particularly valuable for regulatory affairs professionals, quality assurance specialists, and manufacturers involved in the production and reprocessing of reusable medical devices. By the end of the webinar, attendees will be prepared to meet the MDR requirements and maintain the highest standards of safety and efficacy in their products.