Last January 12, 2023, the European Commission published the MDCG 2023-2 regarding the List of Standard Fees. This document defines the term standard fee and provides the template for Notifies Bodies to define the list of fees for conformity assessment activities in accordance with Article 50 of the MDR and Article 46 of the IVDR. This guide allows free access or consultation, enhances transparency, and compares the different fees that may exist between different Notified Bodies. Now, let’s wait for when the Notified Bodies will start using their new template, which must be written in the same language(s) as the Notified Body website.
Yesterday, January 19, 2023, in line with the MDCG 2023-2, the AEMPS informed on new Spanish legislative changes affecting their fees. The Spanish Law 38/2022 (December 27, 2022) introduced changes in the application of fees for medicines, medical devices, cosmetic products, personal care products, pharmaceutical laboratories, and distribution entities. However, the new fees will not come into effect until next June, so that the fees established on December 2022 remain still valid.
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