Notified Body Fee (MDR/IVDR)
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.