The deadline of May 26, 2024 for the formal application for MDR approval of medical devices to the notified bodies is approaching. This application is required for medical devices authorized under MDD to benefit from the extension of the transition period. Usually the application includes the submission of a MDR-compliant technical documentation. For example, the following chapters of the technical documentation require extensive adjustments:

• General safety and performance requirements
• Clinical evaluation
• Market surveillance

Our experts support you in creating your documents in German and English. This includes optimization options with regard to the documentation structure to minimize the effort required to create and maintain your technical documentation.