Will there be additional costs for the Notified bodies bear in future if the proposed Regulations would be implemented as is?

The current business model for Notified Bodies may become unsustainable. The new rules give the European Commission a much larger role in oversight, which will lead to significantly higher administrative fees through the biennial audits from the EU. On top of these rising costs, a specific legal change in the proposal the removal of Article 10(16) —removing the requirement for manufacturers to carry their own liability insurance—shifts more of the legal and financial risk onto the inspection agencies themselves. There are wider reaching implications for patient safety to be considered here as for example, manufacturers could go bankrupt without liability insurance, causing risks to the supply of devices patients depend on, without any recourse.