ABSTRACT
The AMDD applies to all products covered by the “definition of a medical device.” The definition includes (but is not limited to) medical instruments, machines, in vitro diagnostic (IVD) products and software which are intended to be used for human beings for a medical purpose. Critically, for a product to meet the definition of a medical device, it must not achieve its primary intended purpose by pharmacological, immunological or metabolic means. A drug product may be included as a component of the medical device, but can only act to support the medical device achieve its primary indication.
