Traning session: How does the new regulation affect your medical device?

10 Oct 2022
9.00 h

In this training, given by the specialized consultancy Tecnomed, we will explain which are the requirements to sell your product and we will explain the latest news and updates related to the three bases of the CE mark:

  • Technical documentation of the products according to Annexes II and III and the critical points of the documentation
  • Quality Management System according to regulations and ISO 13485 and MDR/IVRD
  • The register of products and organizations in both national (AEMPS) and European (EUDAMED) databases.


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