Standard Fees
Regulation (EU) 2017/745

GMED (CE 0459) Standard Fees* applicable from January 1st, 2024 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€
Administrative fees

Flat

Per technical documentation assessment round: 3400€
 
Per annual “routine” audit: 6465€
 
/ Per technical documentation assessment round:
3400€

 
Per annual “routine” audit:
6465€
Travel time cost (excluding expenses such as hotel cost)

Daily

2450€
 
Location(s), number of auditors

Min. 1225€
 
Auditing
 
Audit (Certification, Recertification, Surveillance, Subcontractor/Supplier)

Flat

Daily

Support time (flat): 700€
 
Certification project manager time (daily): 1115€
 
Decision time (daily): 1140€
 
Preparation/report time (daily): 2450€
 
Audit time (daily):  2450€
 
Company size, number of sites to be audited Min. 13 520€
Unannounced Audit

Flat

Daily

Support time (flat): 700€
 
Certification project manager time (daily): 1115€
 
Decision time (daily): 1140€
 
Preparation/report time (daily): 2450€
 
Audit time (daily): 2450€
 
Sites number 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

2450€ / Min. 2450€ Max. 7350€
 
Documentation Review
 
Technical documentation assessment

Flat

Daily

Support time (flat): 700€
 
Certification project manager time (daily): 1115€
 
Decision time (daily): 1140€
 
Assessment time (daily): 2450€
 
/ Min 18200€ Max 47600€*
Clinical Evaluation Assessment Report (CEAR)

Daily

3180€ / Min 9540€  Max 15900€*
Expert panel consultation

Flat

280€ / 280€
Validation of the Summary of Safety and Clinical Performance (SSCP)

Daily

3180€ / Min. 1590€ Max. 4770€
Consultation with medicinal product authorities

Daily

2450€ / Min. 1255€ Max. 4900€
Consultation with the coordinating competent authority for devices utilizing animal tissues

Daily

2450€ Min. 1255€ Max. 4900€
Evaluation/review of the Periodic Safety Update Report (PSUR)

Daily

2450€ Nb of products included Min. 2450€ Max. 7350€
 
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): 1115€
 
Decision time (daily): 1140€
 
Management fees: 3235€ if audit or 1700€ if technical documentation
 
**If necessary, technical documentation assessment (daily): 2450€ (assessment without clinical evaluation) or 3180€ (assessment with clinical evaluation)
 
/ Min. 4655€ Max. 6190€ (**excluding assessment)
Product extension included in the contractual scope of certification (medical devices under technical documentation sampling)

Flat

Daily

Support time (flat): 175€
 
Certification project manager time (daily): 1115€
 
Decision time (flat): 145€
 
/ Min. 878€  Max. 2770€
Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC

The support time depends on the company’s size

* It could be more in case of “system”. 

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