Medical device recalls are a difficult aspect for medical device manufacturers and distributors, and most importantly, with the end users of these devices. Balancing the needs of the users along with the various regulatory requirements creates challenges for those responsible for deciding and executing recalls. A medical device recall does not always mean that you must stop using the product or return it to the company. It sometimes means that the medical device needs to be checked, adjusted, fixed or provided with additional labeling to ensure the safe and effective use of the product.
This course examines compliance with US FDA, Health Canada, and European Union requirements and regulations. The definitions of the recall classification and type are explained together with the importance of the recall strategy, planning, communication, reporting and record keeping. The value of knowing the FDA 21 CFR requirements (including §7, §806, and §810), Canadian Medical Device Regulations (CMDR) and guidance and European medical devices directives (MDD, AIMDD and IVDD; and MEDDEV guidance) is explained in detail.