Digital Therapeutics (DTx) are medical devices subject to CE marking. Classification under rule 11 of MDR 2017/745, regulatory pathway by risk class and market launch strategy: the essential guide for manufacturers.
Digital Therapeutics (DTx) are Digital Medical Devices designed to treat various pathologies and alleviate their symptoms. Unlike traditional Medical Devices, DTx achieve their therapeutic effects mainly through cognitive-behavioural modifications (such as CBT tools) rather than through pharmacological or immunological means.
DTx have, by definition, a medical purpose and, as such, fall under the definition of Medical Devices under the MDR 2017/745 regulation. Whether helping patients manage chronic diseases or treating the symptoms of mental illness, DTx must demonstrate compliance with the requirements of MDR 2017/745 through the CE marking process. This includes rigorous technical documentation, clinical evaluations and the implementation of a Quality Management System (QMS).
Rule 11 of MDR 2017/745 determines the classification of software Medical Devices based on their intended use and potential risks. DTx are generally classified as Class I, IIa or IIb, depending on the complexity of their features and their impact on patient health. Depending on the classification, the regulatory pathway differs. For Class I medical devices, self-certification is sufficient to obtain CE marking. For higher classes, manufacturers must certify their devices with a Notified Body. It is therefore important to justify the chosen classification in detail, based not only on rule 11 of MDR 2017/745 but also on the MDCG 2019-11 guidance on the qualification and classification of software. This document provides additional guidance to assess whether software meets the criteria of a medical device and to rigorously determine its risk class.
Here are some specific examples for DTx:
For DTx manufacturers, determining the appropriate classification is a key step in balancing speed to market and regulatory compliance. While Class I devices, with limited features, benefit from a simpler CE marking process, technical documentation remains essential to demonstrate compliance with general safety and performance requirements. Conversely, for Class IIa or IIb devices, often associated with complex therapies, manufacturers must prepare more in-depth technical documentation and provide rigorous clinical validation data to meet stricter regulatory requirements.
The CE marking process is essential for digital therapeutics, ensuring they meet high standards of safety and effectiveness. By understanding the classification rules specific to DTx and aligning development strategies with the requirements of MDR 2017/745, manufacturers can successfully introduce their innovative solutions to the European market. Whether self-management tools or complex data-driven interventions, the classification of DTx under rule 11 provides a clear regulatory framework to guide their development.
