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 (daily rate, certificate fee, travel time) 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.
| Activity | Type of Fee | Fee in local currency 2025/26 | Factors influencing the calculation of fee charged | Fee range (min-max) |
|---|---|---|---|---|
| ADMINISTRATIVE CHARGES | ||||
| Application fee | Base rate | 6.400,00 € | Possibly increased expenses for special product categories | |
| Administrative fee related to changes | Base rate | 6.400,00 € | Possibly increased expenses (e.g. number of products, codes and suppliers) | |
| Annual certificate maintenance fee (please give details of activities covered) | Base rate | 1.200,00 € | ||
| Travel time costs (excluding expenses such as hotel costs) | Hourly rate | 150,00 € | ||
| Administrative costs related to handling of external services (laboratories, consultation or travel expenses) | Hourly rate | 400,00 € | Additional third-party fees or preparation of documents, if applicable. | |
| AUDIT ACTIVITY | ||||
| Audit (Certification; Recertification; Surveillance; Subcontractor/Supplier) | Hourly rate | 312,50 € | ||
| Unannounced Audit | Hourly rate | 312,50 € | ||
| Audits as a result of a change | Hourly rate | 312,50 € | Depending on the type of change, additional audits may be required | |
| PRODUCT TESTING | ||||
| Laboratory testing for verification of performance (including preparation and reporting but excluding expenditures incurred for external tests) | Hourly rate | 400,00 € | ||
| DOCUMENTATION REVIEW | ||||
| Technical documentation assessment | Hourly rate | 400,00 € | 7.200,00 – 45.600,00 € | |
| Clinical Evaluation Assessment Report (CEAR) | Hourly rate | 400,00 € | ||
| Expert panel consultation | Hourly rate | 400,00 € | Additional third-party fees or preparation of documents, if applicable. | |
| Validation of the Summary of Safety and Clinical Performance (SSCP) | Hourly rate | 400,00 € | ||
| Consultation with medicinal product authorities | Hourly rate | 400,00 € | Additional third-party fees or preparation of documents, if applicable. | |
| Consultation with human tissue and cells competent authority | Base rate, hourly rate, daily rate | |||
| Consultation with the coordinating competent authority for devices utilizing animal tissues | Base rate, hourly rate, daily rate | |||
| Evaluation/review of the Periodic Safety Update Report (PSUR) | Hourly rate | 400,00 € | ||
| Assessment of changes | Hourly rate | 400,00 € | ||
| Reporting (if not covered above) | Hourly rate | 400,00 € | ||
| Special conditions for manufacturers belonging to SME as defined in Recommendation 2003/361/EC | Covered by application of IAF MD9 Annex D for calculation of audit duration |