NEW | AEMPS Consultation Service for Medical Device Classification

February 29, 2024

The Spanish Agency for medicines and Medical Devices (AEMPS) has published a regulatory consultation service to clarify the qualification and classification of medical devices and in-vitro diagnostic medical devices.

How does this new service work?

  • The purpose of this service is to give regulatory support and guidance on product qualification and classification, as well as promoting innovation.
  • The target audience for this service are MedTech industry developers and manufacturers.
  • AEMPS decides on product qualification and classification applicable to each specific product based on its intended purpose and primary mode of action.
  • Consultations are primarily via meetings or, in exceptional cases, through written reports, generally occurring one month after the confirmed request. A final report is issued within 90 days of request, concluding the procedure. Please note that the AEMPS’ advice is non-binding.
  • The cost per product consultation is 211.61€.


This initiative is a significant step towards clarifying regulatory pathways and fostering MedTech innovation. For those developing or reclassifying products in light of new regulations, this is an invaluable support mechanism.


For further details or to initiate a consultation, do not hesitate to contact us:

Search News & Events

  • Filter by category


Related news and events

NEWS | New Insight on the Implementation of MDR Article 17

Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.

The European Union’s AI Act & its Impact on Medical Devices

The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).

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