The preliminary activity requires the identification of the plan of registration strategy, and relative gap analysis in conformity with the documentation of Regulations 745/2017 and 746/2017, which lead to the design and development of new medical devices or of new registrations of pre-existing medical devices.
This requires the participation of various professionals who are indispensable to be able to respond to different aspects that need to be covered in the registration process. To this end, we believe that it is necessary to involve the Notified Body (NB) from the preliminary phase of the project, which allows us to act in compliance with regulations and to establish collaboration.