Article 50 of the MDR and Article 46 of the IVDR establish the requirement for notified bodies to make their standard fees publicly available. MDCG clarified 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” (MDCG guidance 2019-6). This implies the list of fees of each notified body should be directly and easily accessible on the website of the notified body without any additional steps to be taken by a member of the public.

The requirements of the List of Standard Fees are stated as follows. For further details, please consult the attachment.

Currency
The currency in the list of standard fees should be relevant to the country where the notified body has registered in NANDO. If there are regional differences in fees charged depending on the location of the manufacturer, this should also be indicated in the list.

Language
The list of standard fees should be written in the same language as the website of the notified body. In case of multiple language formats, the list should also be available in the same languages.

Scope and explanation for “List of Standard Fee” items
The templates for the “List of Standard Fees” are provided in the related guidance (MDCG 2023-2). The published list needs to cover all activities corresponding to the scope of the notified body’s designation and the conformity assessment activities which are regularly offered.

Fees can be charged as “flat fees” or “time-based fees”. Notified bodies should indicate the type of fee for each fee item. In addition to such fees, duly justified external costs should be claimed as expenditure. In case fees depend on factors other than time, those should be clearly stated. It is possible to express the expected fees as a range, indicating the factors that influence the fee to be paid.

Attachment:
MDCG 2023-2 - List of Standard Fees

 

 

Reference:
● MDCG 2023-2 - List of Standard Fees