For a period of 10 years after the last product being supplied to the market, and 15 years for implantable devices, the traceability must be available. The traceability should be in such a way as to be able (as any of the economic operators, i.e. importer, distributor, EC REP or legal manufacturer) to demonstrate to the competent authorities, that:
a) and b) the chain of custody per starting from each economic operator to the next of kin
c) any Health Care Professional (HCP) is known to which a product has been supplied.