Notified Bodies: list of standard fees (MDR certification)
[article originally published on June 10, 2021]
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, MDCG 2022-14 position paper emphasizes this obligation and invites NBs to adapt their costs to company sizes.
Notified Body fees
To make the figures comparable: we consider days of 8 hours and audits of 2 days, for a class IIb medical device. Where applicable, annual variations are specified (x%).
| Notified Body | Technical File review | Clinical documentation review | QMS Audit | Certificate | Unannounced Audit | Travel fees | Source |
|---|---|---|---|---|---|---|---|
| €/person /h | € | €/2 people /J | €/person /h | . | |||
| 3EC (=) | 270 € | 250 € | 180 € | 1 000 € | 2 880 € | 40 € | link |
| Berlin Cert | 200 € | 237€ | 1900 € | 40 € | link | ||
| BSI BV (+3%) | 420 € | 245 € | 6 450 € | link | |||
| BUREAU VERITAS ITALIA | ? | ||||||
| CE certiso (=) | 250 € | 250 € | 100 € | 100 € | link | ||
| CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | ? | ||||||
| CERTIQUALITY S.r.l. | ? | ||||||
| DARE!! Services B.V. (=) | 300 € | 300 € | 250 € | 1 100 € | 125 € | link | |
| DEKRA Certification B.V. | ? | ||||||
| DEKRA Certification GmbH | ? | ||||||
| DNV (+3.6%) | 373 € | 285 € | 8 400 € | link | |||
| DQS | 250 € | 250 € | 250 € | 4 000 € | 100 € | ? | |
| Eurofins Expert Services Oy | ? | ||||||
| Eurofins Product Testing Italy | 225 € | 225 € | 500 € | 100 € | link | ||
| GMED | 278 € | 361 € | 278 € | link | |||
| IMQ | ? | ||||||
| Intertek (-4.5%) | 396 € | 545 € | 495 € | link | |||
| ISTITUTO SUPERIORE DI SANITA | 925 € | 412 € | 553 € | 130 € | 8 500 € | link | |
| ITALCERT SRL | 250 € | 1 100€ | link | ||||
| KIWA CERMET ITALIA | ? | ||||||
| MDC (=) | ? | 1 000 € | 6 900 € | 120 € | link | ||
| MEDCERT | 250 € | 225 € | 6 100 € | 120 € | link | ||
| NSAI (=) | 375 € | 375 € | 275 € | 1 300€ | 4 400 € | 137,5 € | link |
| SGS Belgium NV | ? | ||||||
| SGS FIMKO OY (+25%) | 400 € | 320 € | link | ||||
| SIQ (+17%) | 240 € | 250 € | 190 € | 200 € | link | ||
| TÜV NORD CERT GmbH | 369 € | 262 € | 8 925 € * | link | |||
| TÜV NORD Polska | ? | ||||||
| TÜV Rheinland Italia SRL | ? | ||||||
| TÜV Rheinland LGA Products GmbH | ? | ||||||
| TÜV SÜD (+13%) | 430 € | 430 € | 440 € | link | |||
| UDEM (=) | 400 € | 625 € | 250 € | 4000 € * | 100 € | link | |
Data marked * are obtained through customers feedback. The NSAI rates were communicated directly by the NSAI to Qualitiso.
UDEM and MED-CERT are the most compliant notified bodies, with clear fee detail and consideration of company size 👍.
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