Price List for CMI Medical Conformity Assessment Services
The complete CMI price list for medical device conformity assessment services, structured according to the current MDCG guidelines, can be found HERE.
Rates are expressed as a flat rate, in man-hours or man-days.
Rates do not include associated travel, accommodation and other similar costs. These costs will be charged separately according to their actual amount.
Conformity Assessment Pricing Methodology
Checking the fulfilment of all MDR requirements as part of the medical device conformity assessment process requires considerable effort from the notified body and the involvement of a large number of experts. This fact is also reflected in the fees and time required for the services involved. The Czech Metrology Institute, when setting the price for the required services, follows fair and transparent conditions, emphasising as much as possible all the specificities of the contract and the manufacturer, including respect for the interests of small and medium-sized enterprises as defined in European Commission Recommendation 2003/361/EC.
Estimated Price
The price for the conformity assessment is preliminarily estimated in the non-binding quotation provided by CMI on the basis of the sent non-binding inquiry for conformity assessment. However, this Estimated Price is only a first preliminary estimate, as at the time of its determination CMI does not yet have all the information about the medical device under consideration, and therefore, it may differ from the Detailed Estimated Price.
The price thus provisionally estimated shall also form part of the general contract between CMI and the manufacturer.
Detailed Estimated Price
After submitting the complete technical documentation and carrying out its full review, a Detailed Estimated Price is subsequently calculated. The calculation will be based on the relevant rates of the currently valid CMI Price List and the number of hours calculated to perform the relevant tasks in the standard course of the conformity assessment process. This price is then included in the implementation contract for the conformity assessment.
When calculating the amount of time necessary for conformity assessment, the required conformity assessment procedure, the size, organizational structure and number of employees of the manufacturer, the quantity and classification of assessed medical devices, the scope of documentation, the number of suppliers and subcontractors of the manufacturer and other specific aspects of the given contract are taken into account.
The Detailed Estimated Price for the conformity assessment process is valid if the process is carried out in a standard way, the manufacturer provides proper cooperation and has prepared documentation of adequate quality without any non-conformities. In the event that additional costs are incurred by the notified body during the conformity assessment process, such as but not limited to the need to carry out additional actions due to any non-conformities identified, review of the settlement of these non-conformities, additional rounds of iteration, unexpected consultations with external authorities, the need to subcontract certain tasks or tests (e.g. tests performed in an external laboratory) etc., such costs shall be billed based on an amendment to the contract, according to the product of the relevant hourly rates listed in the current valid published CMI Price List and the number of actual hours necessary to perform the tasks in question.
Final Price
The definitive Final Price is therefore only known when the conformity assessment is fully completed and corresponds to the actual scope of all services provided by CMI. The Final Price is paid on the basis of the final invoicing.
Surveillance Activities
The estimated price for the surveillance activities will be calculated as the product of the estimated number of hours spent on the performance of the tasks in question during the surveillance period and the hourly rates specified in the currently valid published CMI Price List. This price shall then form part of the implementation contract for the surveillance activities.
Other Actions
The price of other actions of CMI as a notified body will be determined based on the agreement of the contracting parties before the start of the implementation of a specific action, always based on the currently valid published CMI Price List as of the date of commencement of the action in question