The Sterilization Road Map to Authorization in the EU
Sterile Medical Devices must follow the regulations and standards for CE marking that went into effect May 2021. Medical devices being sold in Europe require a CE mark, even if the product is imported from outside the Economic European Area (EEA). CE marking certifies that a medical device complies with regulatory requirements under European Regulation (MDR 2017/745 and IVDR 2017/746). Upon receipt of the certification / CE mark the product can be freely marked, sold, and marketed anywhere in the Economic European Area (EEA).
In this webinar, the strategic process of obtaining a CE mark, the defined product use and classification, as well as sterilization conformity assessment will be covered. Additionally, the interaction and experiences with contract sterilizers regarding MDR will be reviewed, including key validation information required for obtaining a CE mark for a sterile product.
Medical device manufacturers developing new products or improving the design, or packaging of new or existing products are invited to register for this free webinar to gain a greater understanding of the:
- The process to obtain a CE mark and certification under updated EU and ISO regulations.
- Ensure compliance with regulations and product/process safety.
- Understand the interactions with a contract sterilizer, for the validation process and submission requirements to obtain a CE mark for a sterile medical device.