TEAM-NB supports the objectives of the proposal. However, its members are concerned that the new proposal moves away from the tried-and-true methods used in other industries. Specifically, the proposal reduces the use of independent product testing and scales back “unannounced” audits and technical reviews—tools that have proven effective at keeping manufacturers compliant. Additionally, while individual countries usually oversee the organizations that inspect these devices, this new plan gives the European Commission an unusually high level of control. In short, the proposal shifts away from practical, hands-on oversight in favour of a more centralized, administrative approach without defining how this will be done in a way to maintain the high levels of security and safety of the current system.
