Sterile medical devices must adhere to the regulations and standards for CE marking that came into effect in May 2021. For medical devices to be sold in Europe, a CE mark is required, regardless of whether the product is imported from outside the Economic European Area (EEA). The CE mark certifies that a medical device complies with the regulatory requirements under European Regulation MDR 2017/745 and IVDR 2017/746. Once the certification is obtained, the product can be freely marked, sold, and marketed anywhere within the EEA.
This webinar will guide attendees through the strategic process of obtaining a CE mark for sterile medical devices. It will cover the key steps involved, including defining product use and classification, as well as the conformity assessment and review process. These steps are crucial for ensuring that a medical device meets all necessary regulatory standards and can be legally marketed in Europe.
In addition to the strategic process, the webinar will review interactions and experiences with contract sterilizers regarding MDR compliance. Attendees will learn about the key validation information required for obtaining a CE mark for a sterile product. This includes understanding the specific requirements and documentation needed to demonstrate that the sterilization process is effective and meets regulatory standards.
The presentation will provide practical insights and detailed guidance on navigating the complexities of CE marking for sterile medical devices. By understanding the regulatory framework and the steps required for compliance, participants will be better prepared to achieve CE marking certification for their products.
This webinar is essential for professionals involved in the regulatory compliance, production, and marketing of sterile medical devices. By attending, participants will gain valuable knowledge and tools to navigate the CE marking process successfully, ensuring their products can be legally sold and marketed within the EEA.