New MDCG guidance documents under the MDR and IVDR

The new fees will not come into effect until next June, so that the fees established on December 2022 remain still valid.

The new fees will not come into effect until next June, so that the fees established on December 2022 remain still valid.
January 20, 2023

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.

You can read more at the following links:

AEMPS tasas medicamentos

MDGC standard fees EU 

If you are interested in receiving one or several of these documents, please let us know and we will be happy to provide them.

For further information on this subject please contact us at: info@asphalion.com

Search News & Events

  • Filter by category

Share

Related news and events

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting