Standard Fees
Regulation (EU) 2017/745

GMED (CE 0459) Standard Fees* 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 assessment: 1 910€
 
Per annual “routine” audit: 1 815€
 
/ /
Administrative fees

Flat

Per technical assessment round:
3 400€

 
Per annual “routine” audit:
6 465€

 
/ /
Travel time cost (excluding expenses such as hotel cost)

Hourly

306€
 
Location(s), number of auditors

/
 
Auditing
 
Audit (Certification, Recertification, Surveillance, Subcontractor/Supplier)

Flat

Hourly

Support time (flat): 700€
 
Certification project manager time (hourly): 139€
 
Decision time (hourly): 143€
 
Preparation/report time (hourly): 306€
 
Audit time (hourly): 306€
 
Company size, number of sites to be audited /
Unannounced Audit

Flat

Hourly

Support time (flat): 700€
 
Certification project manager time (hourly): 139€
 
Decision time (hourly): 143€
 
Preparation/report time (hourly): 306€
 
Audit time (hourly): 306€
 
/ /
 
Product testing
 
Laboratory testing – only preparation, testing plan and reporting excluding laboratory testing fees and expenditures incurred for external tests

Hourly

306€ / /
 
Documentation Review
 
Technical documentation assessment

Flat

Hourly

Support time (flat): 700€
 
Certification project manager time (hourly): 139€
 
Decision time (hourly): 143€
 
Assessment time (hourly): 306€
 
/ /
Clinical Evaluation Assessment Report (CEAR)

Hourly

398€ / /
Expert panel consultation

Flat

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

Hourly

398€ / /
Consultation with medicinal product authorities

Hourly

306€ / /
Consultation with the coordinating competent authority for devices utilizing animal tissues

Hourly

306€ / /
Evaluation/review of the Periodic Safety Update Report (PSUR)

Hourly

306€ / /
 
Other services
 
Analysis of changes (excluding audit, technical documentation, or other services fees listed…)

Flat

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.

175€-740€
Certificates copy

Flat

335€ for 5 copies then 170€ per 5 additional

/ /
Recourse

Flat

Hourly

Support time (flat): 175€
 
Certification project manager time (hourly): 139€
 
Decision time (hourly): 143€
 
Management fees: 3 235€ if audit or 1 700€ if technical documentation
 
If necessary technical documentation assessment (hourly): 306€ (assessment without clinical evaluation) or 398€ (assessment with clinical evaluation)
 
/ /
Product extension included in the contractual scope of certification (medical devices under technical documentation sampling)

Flat

Hourly

Support time (flat): 175€
 
Certification project manager time (hourly): 139€
 
Decision time (flat): 145€
 
/ /
Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC

The support time depends on the company size

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