Standard Fees
Regulation (EU) 2017/746
GMED (CE 0459) Standard Fees* 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 assessment: 1 910€ Per annual “routine” audit: 1 815€ |
/ | / |
| Administrative fees |
Flat |
Per technical assessment round: 3 060€ Per annual “routine” audit: 6 465€ Per On-site control “witness tests”: 1 520€ |
/ | / |
| Travel time cost (excluding expenses such as hotel cost) |
Hourly |
306€ |
Location(s), number of auditors
|
/ |
| Auditing |
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| Audit (Certification, Recertification, Surveillance, Subcontractor/Supplier) |
Flat Hourly |
Support time (flat): 700€ Certification project manager time (hourly): 139€ Decision time (hourly): 143€ Preparation/report time (hourly): 306€ Audit time (hourly): 306€ |
Company size, number of sites to be audited | / |
| Unannounced Audit |
Flat Hourly |
Support time (flat): 700€ Certification project manager time (hourly): 139€ Decision time (hourly): 143€ Preparation/report time (hourly): 306€ Audit time (hourly): 306€ |
/ | / |
| On-site control “witness tests”
|
Hourly |
Audit time (hourly): 306€ |
/ | / |
| Product testing |
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| Laboratory testing – only preparation, testing plan and reporting excluding laboratory testing fees and expenditures incurred for external tests
|
Hourly |
306€ | / | / |
| Batch testing
|
Flat |
380€ per batch | / | / |
| Batch testing (complementary element)
|
Flat |
155€ per complementary element | / | / |
| Panel
|
Flat |
620€ or 1 175€ | Depending on type of marker | / |
| Documentation Review |
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| Technical documentation assessment |
Flat Hourly |
Support time (flat): 700€ Certification project manager time (hourly): 139€ Decision time (hourly): 143€ Assessment time (hourly): 306€ |
/ | / |
| Performance Evaluation Assessment Report (PEAR)
|
Hourly |
398€ | / | / |
| Expert panel consultation |
Flat |
280€ | / | / |
| Validation of the Summary of Safety and Performance (SSP)
|
Hourly |
398€ | / | / |
| Consultation of a medicinal product authority for a companion diagnostic and class D
|
Flat |
280€ | / | / |
| Consultation of an EU reference laboratory for performance verification
|
Flat |
395€ | / | / |
| Consultation of an EU reference laboratory for batch testing
|
Flat |
395€ | / | / |
| Evaluation/review of the Periodic Safety Update Report (PSUR)
|
Hourly |
306€ | / | / |
| Other services |
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| Analysis of changes (excluding audit, technical documentation, or other services fees listed…)
|
Flat |
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
|
175€-740€ |
| Certificates copy |
Flat |
335€ for 5 copies then 170€ per 5 additional | / | / |
| Recourse |
Flat Hourly |
Support time (flat): 700€ Certification project manager time (hourly): 139€ Decision time (hourly): 143€ Management fees: 3 235€ if audit or 1 700€ if technical assessment If necessary: Assessment (hourly): 306€ or 398€ |
/ | / |
| Product extension included in the contractual scope of certification (medical devices under technical documentation sampling) |
Flat Hourly |
Support time (flat): 175€ Certification project manager time (hourly): 139€ Decision time (flat): 145€ |
/ | / |
| Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC
|
The support time depends on the company size |
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For more information, please contact:
For GMED SAS: sales@lne-gmed.com | GMED North America: request@lne-gmed.com