List of Standard Fees for Conformity Assessments Activities under the MDR (2017/745)
Notified Body DEKRA Certification B.V. (NB 0344)

Expected fee range

Type of Fee

Fee in local
currency

Factors influencing thecalculation of fee charged

Application fee

Flat€ 1.800

Complexity of the applications,
number of applications≥ € 1.800

Administrative fee related tochanges

Flat

€ 395

Complexity of the change≥ € 395€ 2.300

First certificate - costs forregulatory requirements that
apply to the accreditations as
an auditing organization€ 2.300€ 1.280

Per additional certificate - costs
for regulatory requirementsthat apply to the accreditations
as an auditing organization€ 1.280

Hourly€ 160

Location of manufacturer€ 160 - € 1.920 (day)Hourly€ 450

Testing or consultations
by third party is billed at cost≥ € 450≥ 320€ 3.560 - € 7.120(min-max). In special cases
fees can differ

Administrative charges

Annual certificate
maintenance fee

Travel time costs
Administrative costs related
to handling of external
services (laboratories,consultation or travel
expenses)AuditingFlat

Audit (Certification;
Recertification; Surveillance;
Subcontractor/Supplier)Hourly€ 320

Number of FTE's,increase/decrease factors(MD9), reportingand project management

Unannounced Audit

Daily€ 3.560

Audit tariff per day,preparation and reporting

Hourly€ 450≥ € 450, plus costs incurred for
Dependent on complexity of
external testing will be invoiced
the product(s)at costProduct testing
Laboratory testing (including
preparation and reporting
but excluding expenditures
incurred for external tests)

Effective from 1st of January 2024
5227:1

List of Standard Fees for Conformity Assessments Activities under the MDR (2017/745)
Notified Body DEKRA Certification B.V. (NB 0344)

Type of Fee

Fee in local
currency

Expected fee range
Factors influencing the(min-max). In special cases fees
calculation of fee charged
can differ

Documentation review

Technical documentationassessment

Hourly€ 450

Dependent on risk
classification/complexity ofthe submitted file(s). Project
management andcertification management
Part of the technicaldocumentation assessment
and related project
management
Part of the technicaldocumentation assessment
and related project
management€ 3.600 (day) (1 - 20 days)

Clinical evaluation reportassessment (CEAR)

Hourly€ 450

See Technical documentationassessment above

Expert panel consultation

Hourly€ 450

Validation of the Summary ofSafety and Clinical
Performance (SSCP)

Hourly€ 450

Dependent on complexity ofthe submitted file(s)≥ € 450

Consultation with medicinal
product authorities

Hourly€ 450

Dependent on complexity ofthe submitted file(s)≥ € 450, plus costs incurred forexternal consultation will be
invoiced at cost

Consultation with humantissue and cells competentauthority

Hourly€ 450

Dependent on complexity ofthe submitted file(s)≥ € 450, plus costs incurred forexternal consultation will be
invoiced at cost

Consultation with thecoordinating competentauthority for devices utilizing
animal tissues

Hourly€ 450

Dependent on complexity ofthe submitted file(s)≥ € 450, plus costs incurred forexternal consultation will be
invoiced at cost

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

Hourly€ 450

Dependent on complexity ofthe submitted file(s)≥ € 450

Assessment of changes

Hourly€ 450

Dependent on complexity ofthe submitted file(s)≥ € 450

See Technical documentationassessment above

Disclaimers:Expected fee range might differ due to the complexity of the dossier(s). Reporting is covered in the tariffs shown above. Special
considerations are given to manufacturers that are part of SMEs through the audit calculation which is dependent on the numberof full-time equivalents (FTEs). SMEs will thus (in general) have fewer audit days. In cases where the manufacturer's location
allows the use of local auditors or technical experts, fees may be invoiced in local currency and could vary. Prices in othercurrencies can be provided upon request.
DEKRA Certification B.V.
Meander 1051
6825 MJ Arnhem
For questions about our services, please contact medical.nl@dekra.com or call +31(0)88 96 83005.
Find out more about how DEKRA can support you by visiting our website.

Effective from 1st of January 2024
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