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 👍.