Standard Fees for Notified Bodies under MDR and IVDR

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Standard Fees for Notified Bodies under MDR and IVDR

The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2

This document, endorsed by the Medical Device Coordination Group (MDCG), outlines the standard fees for conformity assessment activities carried out by notified bodies. This document is intended to help notified bodies establish their own lists of standard fees for these activities and make them publicly available, as required by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The MDCG explains that standard fees should be made directly and easily accessible on the website of the notified body, and should be written in the same language as the website. Additionally, the MDCG provides templates for the “List of Standard Fees” to assist notified bodies in defining their own fees for conformity assessment activities. These fees can include flat fees, hourly fees, and fees based on the specific type of activity being performed.

The MDCG clarifies the meaning of “publicly available”, which “implies that a member of the public can access this information at any point in time, without the need for additional steps.” This means that the list of fees should be easily accessible on the website of the notified body without any additional steps, for example, without the need to register as a user of the website or provide contact data. The format of the standard fee table could be any that is accessible on a common website browser.

Moreover, the currency shown should be relevant to the country where the notified body has its registered place of business. If there are regional differences in fees charged depending on the location of the manufacturer, this should also be indicated.

In conclusion, the document serves as an important guide for notified bodies to establish their own fees for conformity assessment activities in line with the MDR and IVDR regulations. The goal of this document is to provide greater transparency and fairness in the fees charged by notified bodies for their conformity assessment services.


Download the article here: mdcg_2023-2_en

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