List of Standard Fees for Conformity Assessments Activities under the IVDR (2017/746)
Notified Body DEKRA Certification B.V. (NB 0344)

Expected fee range

Type of Fee

FeeFactors 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
requirements that apply to theaccreditations as an auditingorganization€ 1.280(min-max). In special cases
fees can differ

Administrative charges

Annual certificate
maintenance fee

FlatTravel time costs

Hourly€ 160

Location of manufacturer€ 160 - € 1.920 (day)Administrative costs related
to handling of externalservices (laboratories,consultation or travelexpenses)

Hourly€ 450

Testing or consultationby third party is billed at cost≥ € 450≥ € 320

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

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

Unannounced Audit

Daily€ 3.560

Audit tariff per day,preparation and reporting€ 3.560 - € 7.120

Laboratory testing forverification of performance(including preparation andreporting but excluding
expenditures
incurred for external tests)

Hourly€ 450

Dependent on complexityof the submitted product(s)≥ € 450, plus costs incurred forexternal testing will be
invoiced at cost

Batch testing

Hourly€ 450

Dependent on complexityof the submitted product(s)≥ € 450, plus costs incurred forexternal testing will be
invoiced at cost

Product testing

Effective from 1st of January 2024
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List of Standard Fees for Conformity Assessments Activities under the IVDR (2017/746)
Notified Body DEKRA Certification B.V. (NB 0344)

Type of Fee

Expected fee range

Fee

Factors influencing thecalculation of fee charged€ 450

Dependent on risk
classification/complexity of thesubmitted file(s). Project
management and certification
management€ 3.600 (day) (1 - 20 days)€ 450

Part of the technicaldocumentation assessment
and related project
management

See Technical documentationassessment above

See Technical documentationassessment above(min-max). In special cases
fees can differ

Documentation review

Technical documentationassessment

Performance Evaluation
Assessment Report (PEAR)

HourlyHourlyExpert panel consultation

Hourly€ 450

Part of the technicaldocumentation assessment
and related project
management

Validation of the Summary of
Safety and Performance(SSP)

Hourly€ 450

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

Consultation of a medicinal
product authority for acompanion diagnostic

Hourly€ 450

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

Consultation of an EU
reference laboratory for
performance verification

Hourly€ 450

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

Consultation of an EU
reference laboratory forbatch testing

Hourly€ 450

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

Evaluation/review of thePeriodic Safety Update
Report (PSUR)

Hourly€ 450

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

Assessment of changes

Hourly€ 450

Dependent on complexity ofthe change(s)≥ € 450Disclaimers:
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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