Medical device CE marking

MDCG published 2023-2: List of standard fees (NB)


The templates for “List of Standard Fees” provided in this guidance document are intended to assist notified bodies defining their list of fees for publication in accordance with MDR Article 50 and IVDR Article 46. Notified bodies can decide the way how they charge for their services and should have documented procedures relating to fees charged for conformity assessment activities. The fee setting should be transparent, items should be clearly indicated in the published list of standard fees. 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.

The document can be downloaded in our library.

Source: European Commission