Comparison of “Notified Body” fees
Comparison of Notified Body (NB) fees for the Medical Devices Regulation.
Article 50 of the Regulation requires Notified Bodies to publish a list of fees associated with certifications and follow-ups, but the information is not always available.
Notified Body fees
To make the figures comparable: we consider days of 8 hours and audits of 2 days.
Notified Body | General TD review | Clinical TD review | Audit QMS | Certification | Audit unexpected | Travel fees | Source |
---|---|---|---|---|---|---|---|
€/person /h | € | €/2 people /J | €/person /h | . | |||
3EC | 270 € | 250 € | 180 € | 1 000 € | 2 880 € | 40 € | link |
BSI BV | 405 € | 240 € | 6 450 € | link | |||
CE certiso | 250 € | 250 € | 100 € | 100 € | link | ||
DARE!! Services B.V. | 300 € | 300 € | 250 € | 1 100 € | 125 € | link | |
DNV | 373 € | 274 € | 8 080 € | link | |||
DQS | 250 € | 250 € | 250 € | 4 000 € | 100 € | link | |
GMED | 390 € * | 485 € * | 6 655 € * | ||||
Intertek | 396 € | 545 € | 495 € | link | |||
MDC | 363 € | 1 000 € | 6 900 € | 120 € | link | ||
NSAI | 188 € | 138 € | 4 400 € | link | |||
SGS FIMKO OY | 287 € * | 287 € * | 250 € * | ||||
TÜV SÜD | 290 € | 390 € | 440 € | link | |||
UDEM | 400 € | 625 € | 250 € | 667 € | 4000 € * | 100 € | link |
Data marked * are obtained through feedback.