"1.1 SME Status Verification
Currently, NBs cannot easily confirm if a manufacturer is a Small or Medium-sized Enterprise (SME). Most NBs only check the number of employees, not the company’s turnover. NBs do not have the resources or expertise to review financial statements. This would create extra work, slow down application processing, and increase costs. Self-declarations from manufacturers are not validated and are therefore unreliable. Team NB suggests that SME status should be verified and recorded in EUDAMED during user registration. This would allow a transparent verification mechanism of a manufacturer (whether SME or not) for all stakeholders, including NBs."
This does not seem to be a logical request and doesnt solve the real issue "Where do these available accountant hours appear from?" If you make every competent authority validate SME status up front, you risk creating a new queue at the front door of EUDAMED actor registration. NBs get relief, but the system as a whole may slow down.
If the goal is one shared truth that NBs can rely on, EUDAMED can be the place to record the outcome, but the verification model needs to be sane. For example:
Maybe in addition to "Substantial Change Notifications," manufacturers will need to submit "Substantial Revenue Change Notifications" in the future?
Currently, NBs cannot easily confirm if a manufacturer is a Small or Medium-sized Enterprise (SME). Most NBs only check the number of employees, not the company’s turnover. NBs do not have the resources or expertise to review financial statements. This would create extra work, slow down application processing, and increase costs. Self-declarations from manufacturers are not validated and are therefore unreliable. Team NB suggests that SME status should be verified and recorded in EUDAMED during user registration. This would allow a transparent verification mechanism of a manufacturer (whether SME or not) for all stakeholders, including NBs."
This does not seem to be a logical request and doesnt solve the real issue "Where do these available accountant hours appear from?" If you make every competent authority validate SME status up front, you risk creating a new queue at the front door of EUDAMED actor registration. NBs get relief, but the system as a whole may slow down.
If the goal is one shared truth that NBs can rely on, EUDAMED can be the place to record the outcome, but the verification model needs to be sane. For example:
- Store only a verified status and date, not financial documents, to reduce sensitivity and data handling risk.
- Use a standard SME declaration format, then verify only when risk triggers fire, like borderline thresholds, rapid growth, ownership complexity, or random audit sampling.
- For complex structures, require consolidated accounts or an external attestation, because the linked enterprise rules are where shortcuts might be abused.
- Make it time limited, for example valid for a year, so the database reflects reality.
Maybe in addition to "Substantial Change Notifications," manufacturers will need to submit "Substantial Revenue Change Notifications" in the future?
