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 | ||||
| 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 | ||||
| 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 | ||||
| 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 | ||||
| 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 | ||||
| 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 | |||
For more information, please contact:
For GMED SAS: sales@lne-gmed.com | GMED North America: info@lne-gmed.com