A fee reduction of up to 50% for SMEs and the imposition of mandatory deferred payment schedules would have a major impact on the Notified Bodies viability. The large majority of medical device and IVD manufacturers fall under the SME definition and are therefore the customers/users of conformity assessments carried out by Notified Bodies.
Another major concern for financial sustainability is the proposed, almost integral removal of all Notified Body surveillance activities. Implementing this proposal would make Notified Bodies unattractive for their stakeholders, but also for NB ability to hire and maintain skilled technicians, with the risk of eventually creating a bottle neck in the overall system for the remaining activities that NBs will take on. These reductions would apply to all SMEs, not simply those based within the EU.
