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Notified Body Fee (MDR/IVDR)

Notified Body Fee

IVDR & MDR Notified Bodies: List of Standard Fees

Man-Hour Calculation

Class Is/r/m and Class IIa: 16 Hours of Technical Review and 2 Days of QMS review.

Class IIb: 16 – 24 Hours of Technical Review and 2-3 Days of QMS review.

Class III: 24- 32 Hours of Technical Review and 2-3 Days of QMS review.

Fee charged by multiple Notified Bodies *

NOTIFIED BODY

TECHNICAL FILE REVIEW

CER REVIEW

QMS AUDIT

SOURCE

3EC 270 € 250 € 180 € link
Berlin Cert 200 € NA 237€ link
BSI BV 420 € NA 245 € link
CE CERTISO 250 € 250 € NA link
DARE 300 € 300 € 250 € link
DNV 373 € NA 285 € link
DQS 250 € 250 € 250 € NA
EUROFINS 225 € NA 225 € link
GMED 278 € 361 € 278 € link
INTERTEK 396 € 545 € 495 € link
ISDS 925 € 412 € 553 € link
ITALCERT SRL 250 € NA NA link
MDC NA NA NA link
MEDCERT 250 € NA 225 € link
NSAI 375 € 375 € 275 € link
SGS FIMKO OY NA 400 € 320 € link
SIQ 240 € 250 € 190 € link
TÜV NORD 369 € NA 262 € link
TÜV SÜD 430 € 430 € 440 € link
UDEM 400 € 625 € 250 € link
  • Fees is €/person /hr
  • Certificate issue fee 1200-1500 Euros
  • Unannounced Audit fee vary between 4000-6000 Euros.

 

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.

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