MDR customer questionnaire / description / standard fees

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Projectmanagement Medical

The manufacturer applies for the corresponding conformity assessment procedure based on the product classification.

In order to be able to prepare a quotation for you, we need some information. Please fill in the Customer questionnaire (The questionnaire is not displayed in your web browser? We recommend downloading the PDF and opening it with Adobe Acrobat Reader) and send it to us electronically (submitted documents and correspondence must be in German or English only).

More detailed information on each step of the conformity assessment procedure (taking into account the relevant annexes) can be found in our Description of the conformity assessment procedure according to Regulation (EU) 2017/745 or the QM system certification according to EN ISO 13485.

Fees are based on the currently valid daily rates (8 hours per day) and reflect factors such as company size, production sites, number and complexity of products, etc. TÜV NORD CERT GmbH has the right to adjust the remuneration by up to 5% per year. In the event that an adjustment of more than 5% is necessary, the contractor shall inform the client accordingly in writing. Daily rates may vary regionally. Please note that clinical evaluation, biocompatibility, software and validations are also included in the assessment of technical documentation.

If you have any further questions, please do not hesitate to contact us.

 

List of standard fees following MDCG 2023-2

Activity

Type of Fee

Fee in local currency 2024

Factors influencing the calculation of fee charged

Fee range (min-max)

         

ADMINISTRATIVE ASPECTS

       

Application fee

Flat

8.525 €

Possibly increased expenses for special product categories (e.g. substance based products); Quality and structure of provided documentation

 

Administrative fee related to changes

Flat

6.975 €

Possibly increased expenses (e.g. number of products, codes and suppliers)

 

Annual certificate administrative fee

Flat

1.200 €

   

Travel timecosts (excluding expenses such as hotel costs)

Hourly rate

130,00 €

   

Administrative costs related to handling of external services (e.g. laboratories or consultation)

Hourly rate

387,50 €

Additional third-party fees or preparation of documents, if applicable.

 
         

AUDIT ACTIVITY

       

Audit (Certification; Recertification; Surveillance; Subcontractor/Supplier; Projectcoordination)

Hourly rate

287,50 €

IAF MD 9 Annex D; Size and complexity of the Organization

 

Unannounced Audit

Hourly rate

287,50 €

   
         

PRODUCT TESTING

       

Laboratory testing (including preparation and reporting but excluding expenditures incurred for external tests)

Hourly rate

387,50 €

   
         

DOCUMENTATION EVALUATION

       

(Technical) documentation assessment

Hourly rate

387,50 €

Depending on the risk class of the device; Quality and structure of provided (Technical) documentation

6.975,00 € – 67.425,00 €

Clinical evaluation report assessment (CEAR)

Hourly rate

387,50 €

Depending on the risk class of the device; Quality and structure of provided CER documentation; Fees for CER assessment are included in fees for Technical documentation assessment

 

Expert panel consultation

Hourly rate

387,50 €

Additional third-party fees or preparation of documents, if applicable.

 

Validation of the Summary of Safety and Clinical Performance (SSCP)

Hourly rate

387,50 €

   

Consultation with medicinal product authorities

Hourly rate

387,50 €

Additional third-party fees or preparation of documents, if applicable.

 

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

Hourly rate

387,50 €

   

Expert review as a result of a change

Hourly rate

387,50 €

Depending on the nature of the change, additional Technical Documentation review may be required

 

Audit as a result of a change

Hourly rate

287,50 €

Depending on the nature of the change, additional Audits may be required

 

Expert reporting (if not covered above)

Hourly rate

387,50 €

For-the-cause assessments, e.g.: authority requests, Vigilance assessment, requests from the market; Assessment according to actual efforts

 

Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC

   

IAF MD9 Annex D for calculation of audit duration

 

Please feel free to contact us if you have any questions