Standard Fees
Regulation (EU) 2017/745
GMED (CE 0459) Standard Fees* applicable from January 1st, 2026 for Conformity Assessment Activities under the MDR (Regulation (UE) 2017/745)
*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 devices(s) (flat): 571€ Renewal of a system certificate covering more than 10 devices (flat): 1137€ |
Device number |
Min. 571€ Max. 1137€ |
| Administrative fees* |
Flat |
Per technical documentation assessment session: 3468€
Per annual “routine” audit (flat): |
Type of service | Per technical documentation assessment session: 3468€ Per annual “routine” audit: 6594€ to 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 (daily): 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 or renewal: 1163€ 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 time (daily): 581€ Preparation/reporting time (daily): 2576€ Administrative costs: not applicable Audit time (daily): 2576€Travel time: depends on the location of the manufacturing site to be audited |
Number of sites to be audited and scope | Min. 9 627€ Max. 11 559€ |
| 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 |
Tests: proposal of a corresponding quotation on the basis of the quotation provided by the testing laboratory | / | / |
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 18564€ Max 48552€** |
| Clinical Evaluation Assessment Report (CEAR)
|
Daily |
3244€ | / | Min. 9730€ Max. 16218€** |
| Expert panel consultation |
Flat |
571€ | / | 571€ |
| Validation of the Summary of Safety and Clinical Performance (SSCP)
|
Flat Daily |
Certification Project Manger time (flat): 714€ Assessor/Combination of substances Expert time (daily): 2576 € |
/ | Min. 1622€ Max. 4865€ |
| Consultation with medicinal product authorities
|
Daily |
On the basis of the quotation received by the Competent Authority of EMA | / | / |
| GMED fee – Consultation with the coordinating competent authority for devices utilizing animal tissues
|
Daily |
2576€ | Min. 1280€ Max. 4998€ | |
| Evaluation/review of the Periodic Safety Update Report (PSUR)
|
Daily |
Support time (flat): 179€ Certification project manager time (flat): 280€ Assessor/Expert/Clinician time (daily): 2576€ |
Depends of the number of products included | Min. 2980€ Max. 5505€ |
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 (flat): 179€ Certification project manager time (daily): 571€ Decision-making time (flat): 581€ Management costs: 3300€ for audits or 1734€ for technical documentation If necessary, assessment: Evaluator/Expert time (daily): 2576€ Clinician time (daily): 3244€ |
Assessment / Audit | Min. 3170€ Max. 4631€ excluding assessment |
| Product extension included in the contractual scope of certification (medical devices under technical documentation sampling) |
Flat Daily |
Decision-making time (flat): 148€
Certification project manager time (daily): 1137€ |
/ | Min. 1285€ |
| *Specific 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 | GMED North America: info@lne-gmed.com