Standard Fees
Regulation (EU) 2017/746
GMED (CE 0459) Standard Fees* applicable from January 1st, 2025 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 |
||||
| Application fees |
Flat |
Per technical documentation assessment: 1910€ Per annual “routine” audit: 1815€ |
/ | Per technical documentation assessment: 1910€
Per annual “routine” audit: 1815€ |
| Renewal application fees |
Flat |
Renewal of a system certificate covering 1 to 10 device(s) (flat): 560€ Renewal of a system certificate covering more than 10 devices (flat): 1115€ |
Device numbers |
Min. 560€ Max. 1115€ |
| Administrative fees* |
Flat |
Per technical documentation assesssment session: 3060€ Per “routine” annual audit (flat): CE audit: 6465€ CE+ISO audit: 7430€ |
Type of device | Per technical documentation assesssment session: 3060€ Per “routine” annual audit: Min. 6465€ Max. 7430€ |
| Travel time cost (excluding expenses such as hotel cost) |
Daily |
2525€ |
Location(s), number of auditors
|
Min. 1263€ |
| Auditing |
||||
| Audit (Certification, Recertification, Surveillance, Subcontractor/Supplier) Documentary Audit |
Flat Daily
|
Examination of application (Initial/Renewal): Support time (flat): 700€ Certification project manager time (flat): 1115€ General part audit: Support time (flat): 700€ Certification project manager time (flat): 2230€ Preparation/reporting (flat): 2525€ Audit time (daily): 2525€ Decision-making time (daily): Initial: 1140€ Renewal or follow-up: 570€ Documentary audit: Support time (flat): 700€ Certification project Manager time (flat): 1115€ Assessor/Auditor/Expert time (daily): 2525€ Decision-making time (flat): 570€ |
Company size, number of sites to be audited | Min. 15 015€ |
| Unannounced Audit |
Flat Daily |
Support time (flat): 700€ Certification project manager time (daily): 2230€ Decision-making time (daily): 570€ Preparation/reporting time (daily): 2525€Audit time (daily): 2525€ Travel time: depends on the location of the manufacturing site to be audited |
Site number to be audited and scope | Min. 10 850€ Max. 13 300€ |
| On-site control “witness tests”
|
Flat
Daily |
Support time (flat): 175€ Preparation/report (flat): 1225€ Certification project manager/ Batch release file evaluator time (daily): 2525€ |
Company size, sites number to be audited | Min. 3925€ Max. 4710€ |
| Product testing |
||||
| Laboratory testing – only preparation, testing plan and reporting excluding laboratory testing fees and expenditures incurred for external tests
|
Daily |
2525€ | Min. 2525€ Max 7350€ |
|
| Batch testing
|
Flat |
305€ per batch | / | 305€ |
| Batch testing (complementary element)
|
Flat |
165€ per complementary element | / | 165€ |
| Panel
|
Flat |
555€ or 1110€ Decision time: 65€ |
Depending on the type of marker | Min. 620€ Max. 1175€ |
| Documentation Review |
||||
| Technical documentation assessment |
Flat Daily |
Support time (flat): 700€ Certification project manager time (daily): 1115€ Decision time (daily): 1140€ Assessment time (daily): 2525€ |
/ | Min.8400€ Max.18200€** |
| Performance Evaluation Assessment Report (PEAR)
|
Daily |
3180€ | / | Min.6360€ Max.12720€** |
| Expert panel consultation |
Flat |
280€ | / | 280€ |
| Validation and SSCP management of class C and D devices
|
Flat Daily |
Support time (flat): 700€ Assessor/Expert time (daily): 2525€ |
/ | Min. 1438€ 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)
|
Flat
Daily |
Support time (flat): 175€ Certification project manager time (flat): 280€ Assessor/ Expert/ Clinician time (daily): 2525€ |
Depends on the number of products included | Min. 2980€ Max. 5505€ |
| Other services |
||||
| 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: 175€ (flat) Certification project manager time (daily): 560€ Decision-making time (flat): 570€ Management costs: 3235€ for audits or 1700€ for technical documentation If necessary, assessment (daily): Assessor/Expert time: 2525€ Clinician time: 3180€ |
/ | Min. 3005€ Max. 4540 (**Excluding assessment) |
| Product 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-making time (flat): 145€ |
/ | Min. 1435€ Max. 2550€ |
| *Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC
|
A special pricing structure for SMEs has been introduced: Application of an audit administration fee discount based on company size (to be applied from 2nd half of 2025) -50% if SME <50 employees -25% if SME or equal to 50 < 249 |
|||
** It could be more in case of “system”.
For more information, please contact:
For GMED SAS: sales@lne-gmed.com | For GMED NA: info@lne-gmed.com