Standard Fees
Regulation (EU) 2017/745

GMED (CE 0459) Standard Fees* applicable from January 1st, 2025 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: 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 devices(s) (flat): 560€ Renewal of a system certificate covering more than 10 devices (flat): 1115€	Device number	Min. 560€ Max. 1115€
Administrative fees*	Flat	Per technical documentation assessment session: 3400€ Per annual “routine” audit (flat): CE audit: 6465€ CE+ISO audit: 7430€	Type of service	Per technical documentation assessment session: 3400€ Per annual “routine” audit: 6465€ to 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 (daily): 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 or renewal: 1140€ 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 time (daily): 570€ Preparation/reporting time (daily): 2525€ Administrative costs: not applicable Audit time (daily): 2525€	Number of sites to be audited and scope	Min. 10 850€ Max. 13 300€
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): 700€ Certification project manager time (daily): 1115€ Decision time (daily): 1140€ Assessment time (daily): 2525€	/	Min 18200€ Max 47600€**
Clinical Evaluation Assessment Report (CEAR)	Daily	3180€	/	Min. 9540€ Max. 15900€**
Expert panel consultation	Flat	560€	/	560€
Validation of the Summary of Safety and Clinical Performance (SSCP)	Flat Daily	Certification Project Manger time (flat): 700€ Assessor/Combination of substances Expert time (daily): 2525 €	/	Min. 1590€ Max. 4770€
Consultation with medicinal product authorities	Daily	On the basis of the quotation received by the Competent Authority of EMA	/	/
Consultation with the coordinating competent authority for devices utilizing animal tissues	Daily	2525€		Min. 1255€ Max. 4900€
Evaluation/review of the Periodic Safety Update Report (PSUR)	Daily	Support time (flat): 175€ Certification project manager time (flat): 280€ Assessor/Expert/Clinician time (daily): 2525€	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	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 (flat): 175€ Certification project manager time (daily): 560€ Decision-making time (flat): 570€ Management costs: 3235€ for audits or 1700€ for technical documentation If necessary, assessment: Evaluator/Expert time (daily): 2525€ Clinician time (daily): 3180€	Assessment / Audit	Min. 3005€ Max. 4540€ excluding assessment
Product extension included in the contractual scope of certification (medical devices under technical documentation sampling)	Flat Daily	Decision-making time (flat): 145€ Certification project manager time (daily): 1115€	/	Min. 1260€
*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 the second half of 2025): -50% if SME < 50 employees -25% if SME > or equal to 50 < 249 employees