The hot issues are related to compliance, EU MDR and recalls.
Learn about the new subclass for Class I reusable devices under MDR and the necessary steps to ensure compliance.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.