What constitutes a counterfeit medical device or a fraudulent activity requiring notification of RAs?

For all practical purpose: 

• A counterfeit medical device is a medical device that is represented as, and likely to be mistaken for, an authentic medical device with a valid marketing authorization, or whose identity, nature and/or source are fraudulently misrepresented, or that is otherwise intended to defraud. 
• A fraudulent activity is an intentional, reckless, dishonest and recurrent, or systematic, activity resulting, for example, in the production of a counterfeit product, or in the creation of fake records, false representations, or the alteration of genuine records to imply compliance.  The unintentional failure to comply with requirements, despite due diligence, does not qualify as fraudulent activity.