Authorised Representatives, Importers and Distributors
The Regulations clarify the respective responsibilities of authorised representatives, importers and distributors, as well as the tasks that could be delegated by the legal manufacturer to the authorised representative.
The Regulations emphasise a life-cycle approach to safety, adding requirements for pre-market clinical evidence and reinforced post-market monitoring (‘vigilance’ and ‘post-market surveillance’).
The Regulations also introduce a system of unique device identifiers (UDIs) to allow the identification of medical devices and facilitate their traceability.
In addition, EUDAMED – the new European database for medical devices and in vitro diagnostic medical devices – will play a central role in making basic data widely available, and in reporting and tracking incidents.