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 |