For medical devices incorporating a medicinal substance, the process of review of their technical documentation under the European Directives takes significantly more time than for other devices due to their high risk. These products being innovative, helping the industry to identify and address the main pitfalls, would enhance a safer and potentially faster access to the market. Medical devices incorporating a medicinal substance are among the most complex categories. Due to their high risk and their particular aspects, the process of their pre-market approval review requires significant resources, health actors’ cooperation and time by regulators. Several factors could impact the outcome of the review and delay the processing of those files due to incomplete files, information not clearly indicated, differences with the format expected by the Competent Authority and/or the Notified Body, etc. This workshop aims to highlight the main pitfalls in avoiding submitting a CE application for this kind of product, and other main elements which could influence the process of review. In the context of MDR, this session will also present some new changes brought by this regulation impacting those products (Article 117 etc.).