Standard Fees
Regulation (EU) 2017/746
GMED (CE 0459) Standard Fees* applicable from January 1st, 2026 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: 1948€ Per annual “routine” audit: 1851€ |
/ | Per technical documentation assessment: 1948€
Per annual “routine” audit: 1851€ |
| Renewal application fees |
Flat |
Renewal of a system certificate covering 1 to 10 device(s) (flat): 571€ Renewal of a system certificate covering more than 10 devices (flat): 1137€ |
Device numbers |
Min. 571€ Max. 1137€ |
| Administrative fees* |
Flat |
Per technical documentation assessment session: 3468€ Per “routine” annual audit (flat): CE audit: 6594€ CE+ISO audit: 7579€ |
Type of device | Per technical documentation assessment session: 3468€ Per “routine” annual audit: Min. 6594€ Max. 7579€ |
| Travel time cost (excluding expenses such as hotel cost) |
Daily |
2576€ |
Location(s), number of auditors
|
Min. 1288€ |
| Auditing |
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| Audit (Certification, Recertification, Surveillance, Subcontractor/Supplier) Documentary Audit |
Flat Daily
|
Examination of application (Initial/Renewal): Support time (flat): 714€ Certification project manager time (flat): 1137€ General part audit: Support time (flat): 714€ Certification project manager time (flat): 2275€ Preparation/reporting (flat): 2576€ Audit time (daily): 2576€ Decision-making time (daily): Initial: 1163€ Renewal or follow-up: 581€ Documentary audit: Support time (flat): 714€ Certification project Manager time (flat): 1137€ Assessor/Auditor/Expert time (daily): 2576€ Decision-making time (flat): 581€ |
Company size, number of sites to be audited | Min. 15 315€ |
| Unannounced Audit |
Flat Daily |
Support time (flat): 179€ Certification project manager time (daily): 1139€ Decision-making time (daily): 581€ Preparation/reporting time (daily): 2576€ Audit time (daily): 2576€ Travel time: depends on the location of the manufacturing site to be audited |
Site number to be audited and scope | Min. 9 627€ Max. 11 559€ |
| On-site control “witness tests”
|
Flat
Daily |
Support time (flat): 179€ Preparation/report (flat): 1250€ Certification project manager/ Batch release file evaluator time (daily): 2576€ |
Company size, sites number to be audited | Min. 4003€ Max. 4804€ |
| 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 |
2576€ | Min. 2576€ Max 7497€ |
|
| Batch testing
|
Flat |
311€ per batch | / | 311€ |
| Batch testing (complementary element)
|
Flat |
168€ per complementary element | / | 168€ |
| Panel
|
Flat |
566€ or 1132€ Decision time: 66€ |
Depending on the type of marker | Min. 632€ Max. 1198€ |
| Documentation Review |
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| Technical documentation assessment |
Flat Daily |
Support time (flat): 714€ Certification project manager time (daily): 1137€ Decision time (daily): 1163€ Assessment time (daily): 2576€ |
/ | Min.8568€ Max.18564€** |
| Performance Evaluation Assessment Report (PEAR)
|
Daily |
3244€ | / | Min.6487€ Max.12974€** |
| Expert panel consultation |
Flat |
286€ | / | 286€ |
| Validation and SSCP management of class C and D devices
|
Flat Daily |
Support time (flat): 714€ Assessor/Expert time (daily): 2576€ |
/ | Min. 1467€ Max. 4865€ |
| Consultation of a medicinal product authority for a companion diagnostic and class D
|
Flat |
286€ | / | 286€ |
| GMED fee – Consultation of an EU reference laboratory for batch testing – Preparation of the test plan, establishment of Batch Testing Criteria (BTC) | Flat |
749€ |
/ | 749€ |
|
|
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| Evaluation/review of the Periodic Safety Update Report (PSUR)
|
Flat
Daily |
Support time (flat): 179€ Certification project manager time (flat): 286€ Assessor/ Expert/ Clinician time (daily): 2576€ |
Depends on the number of products included | Min. 3040€ Max. 5615€ |
| Other services |
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| Analysis of changes (excluding audit, technical documentation, or other services fees listed…)
|
Flat |
589€ | / | 589€ |
| Vigilances (excluding any needed assessments) |
Flat |
Minimum 179€ 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. 179€ Max. 755€ |
| Certificates copy |
Flat |
342€ for 5 copies then 173€ per 5 additional | / | Min. 342€ |
| Recourse |
Flat Daily |
Support time: 179€ (flat) Certification project manager time (daily): 571€ Decision-making time (flat): 581€ Management costs: 3300€ for audits or 1734€ for technical documentation If necessary, assessment (daily): Assessor/Expert time: 2576€ Clinician time: 3244€ |
/ | Min. 3065€ Max. 4631 (**Excluding assessment) |
| Product extension included in the contractual scope of certification (medical devices under technical documentation sampling) |
Flat Daily |
Support time (flat): 179€ Certification project manager time (daily): 1137€ Decision-making time (flat): 148€ |
/ | Min. 1464€ Max. 2601€ |
| *Special conditions for SME-type manufacturers as defined in Recommendation 2003/361/EC
|
Consideration of specific SME pricing The definition is based on the European Commission Recommandation 2003/361/EC, which sets out the criteria relating to headcount, turnover and balance sheet total that determine the classification of companies by category. Application of a discount based on the company size for audit administrative fees: Medium-sized enterprise: <250 employees ; turnover ≤50M€ or annual balance sheet ≤43M€ Applied Pricing: -25% administrative fees on audit activity Small enterprise: <50 employees ; turnover ≤10M€ or annual balance sheet ≤10M€ Applied Pricing: -50% administrative fees on audit activity Very small enterprise: <10 employees ; turnover ≤2M€ or annual balance sheet ≤2M€ Applied Pricing: -50% administrative fees on audit activity |
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For more information, please contact:
For GMED SAS: sales@lne-gmed.com | For GMED NA: info@lne-gmed.com