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
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
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
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
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€
Consultation of an EU reference laboratory for performance verification within the framework of BTC testing	Flat	749€	/	749€
GMED fee – Consultation of an EU reference laboratory for batch testing – Preparation of the test plan, establishment of Batch Testing Criteria (BTC)	Flat	402€	/	402€
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
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