Notified Bodies: list of standard fees (MDR certification)

By Guillaume Promé
Sep. 12, 2022 Regulation (EU) 2017/745

[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 390 € * 485 € * 6 655 € * ?
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 👍.