Price list
List of Basic Fees for Conformity Assessment Services of Medical Devices According to Regulation (EU) 2017/745 | |||
| Activity | Type of Fee | Amount of the fee | Factors influencing the calculation of fee charged |
| Application fee | Flat | 1 200 EUR / 2 000 EUR | The fee depends on the quantity of products, class of products and the number of suppliers |
| Audit (Certification| Recertification| Surveillance| Subcontractor audit, screening audit, Unannounced Audit, product testing) | Hourly rate | 403 EUR / 508 EUR* | |
| Technical documentation assessment | Hourly rate | 403 EUR / 508 EUR* | |
| Clinical evaluation report assessment | Hourly rate | 403 EUR / 508 EUR* | |
| Issuance of a complete set of certificates (in Polish and English) | Flat | 100 EUR
| |
| Special procedures | Hourly rate | 403 EUR / 508 EUR* | The fee depends on the class of products |
| Preparation for the audit, development of Technical Documentation Evaluation Report, development of Clinical Evaluation Report, development of Audit Report | Hourly rate | 403 EUR / 508 EUR* | |
| Administrative fee | Flat | 1 200 EUR | |
| Travel time costs (excluding expenses such as hotel costs) | Hourly rate | 100 EUR / 1 auditor | The fee depends on the length of the journey and the number of auditors/experts/translators participating in the audit |
* fee for companies employing up to 5 employees / fee for companies employing more than 5 employees
Applicable from 01.01.2026
MDR_Cennik_EN_Rev.02/12.2025