26 May 2024 was the last call to apply for MDR for legacy devices and take advantage of the transitional periods! The first condition was to submit the application to the Notified Body by May 26, 2024. Once this condition is met, you must then sign an agreement with the notified body by September 26, 2024. Failure to meet either condition means manufacturers will not be able to utilize the transitional periods
Medical device manufacturers must systematically collect and evaluate clinical data both before and after their products are approved. The EU Medical Devices Regulation (MDR) has increased the requirements for the scope and quality of this clinical data.
Many manufacturers may not realize how crucial clinical data is for proving their products comply with regulations. This is important not only for product approval but also for ongoing “post-market activities,” particularly “post-market clinical follow-up.
It’s also crucial to assess whether you can prepare the necessary preclinical, clinical, and technical data as well as complete technical documentation and quality management system documentation within the time frame set by the notified body.