Standard Fees
Regulation (EU) 2017/746
GMED (CE 0459) Standard Fees* applicable from January 1st, 2024 for Conformity Assessments Activities under the IVDR (Regulation (EU) 2017/746)
*Applicable fees for activities managed by GMED French offices
| Activity | Type of Fee | Amount of fee (excluding VAT) |
Factors influencing the calculation of fee charged |
Fee range (min-max) |
| Administrative charges |
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| Application fees |
Flat |
Per technical documentation assessment: 1910€ Per annual “routine” audit: 1815€ |
/ | Per technical documentation assessment: 1910€
Per annual “routine” audit: 1815€ |
| Administrative fees |
Flat |
Per technical documentation assessment round: 3060€ Per annual “routine” audit: 6465€ Per On-site control “witness tests”: 1520€ |
/ | Per technical documentation assessment round: 3060€ Per annual “routine” audit: 6465€ Per On-site control “witness tests”: 1520€ |
| Travel time cost (excluding expenses such as hotel cost) |
Daily |
2450€ |
Location(s), number of auditors
|
Min. 1225€ |
| Auditing |
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| Audit (Certification, Recertification, Surveillance, Subcontractor/Supplier) |
Flat Daily |
Support time (flat): 700€ Certification project manager time (daily): 1115€ Decision time (daily): 1140€ Preparation/report time (daily): 2450€ Audit time (daily): 2450€ |
Company size, number of sites to be audited | Min. 13 520€ |
| Unannounced Audit |
Flat Daily |
Support time (flat): 700€ Certification project manager time (daily): 1115€ Decision time (daily): 1140€ Preparation/report time (daily): 2450€ Audit time (daily): 2450€ |
Site number to be audited and scope | Min. 10 850€ Max. 13 300€ |
| On-site control “witness tests”
|
Daily |
Audit time (daily): 2450€ |
Company size, sites number to be audited | Min. 1225€ Max. 2450€ |
| Product testing |
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| Laboratory testing – only preparation, testing plan and reporting excluding laboratory testing fees and expenditures incurred for external tests
|
Daily |
2450€ | / | Min. 2450€ Max. 7350€ |
| Batch testing
|
Flat |
305€ per batch | / | 305€ |
| Batch testing (complementary element)
|
Flat |
165€ per complementary element | / | 165€ |
| Panel
|
Flat |
555€ or 1110€ | Depending on the type of marker | Min. 550€ Max. 1110€ |
| Documentation Review |
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| Technical documentation assessment |
Flat Daily |
Support time (flat): 700€ Certification project manager time (daily): 1115€ Decision time (daily): 1140€ Assessment time (daily): 2450€ |
/ | Min 8400€ Max 18200€* |
| Performance Evaluation Assessment Report (PEAR)
|
Hourly |
3180€ | / | Min 6360€ Max 12720€* |
| Expert panel consultation |
Flat |
280€ | / | 280€ |
| Validation of the Summary of Safety and Performance (SSP)
|
Daily |
3180€ | / | Min. 1590€ Max. 4770€ |
| Consultation of a medicinal product authority for a companion diagnostic and class D
|
Flat |
280€ | / | 280€ |
| Consultation of an EU reference laboratory for batch testing
|
Flat |
395€ | / | 395€ |
| Evaluation/review of the Periodic Safety Update Report (PSUR)
|
Daily |
2450€ | Nb of products included | Min. 2450€ Max. 7350€ |
| Other services |
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| Analysis of changes (excluding audit, technical documentation, or other services fees listed…)
|
Flat |
530€ | / | 530€ |
| Vigilances (excluding any needed assessments) |
Flat |
Minimum 175€ per vigilance | Duration depending on the seriousness of the incident through the impact on the health of the patient/user and accumulation of vigilance over a given period
|
Min. 175€ Max. 740€ |
| Certificates copy |
Flat |
335€ for 5 copies then 170€ per 5 additional | / | Min. 335€ |
| Recourse |
Flat Daily |
Support time (flat): 700€ Certification project manager time (daily): 1115€ Decision time (daily): 1140€ Management fees: 3235€ if audit or 1700€ if technical assessment **If necessary: Assessment (daily): 2450€ or 3180€ |
/ | Min. 4655€ Max. 6190€
(** Excluding assessment) |
| 6Product extension included in the contractual scope of certification (medical devices under technical documentation sampling) |
Flat Daily |
Support time (flat): 175€ Certification project manager time (daily): 1115€ Decision time (flat): 145€ |
/ | Min. 878€ Max. 2770€ |
| Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC
|
The support time depends on the company’s size |
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* It could be more in case of “system”.
For more information, please contact:
For GMED SAS: sales@lne-gmed.com | GMED North America: request@lne-gmed.com