Notified Body Coordination “MDD&MDR”

Many Notified Bodies (NBs) assigned under the previous directive (MDD) have not gone through the MDR designation process, so it is important to verify if your NB has been designated under the MDR. If not, you will need to change the NB to continue working on the MDR certificate for your device. To make the transition as smooth as possible, it is highly recommended that you establish a good working relationship with your NB so you can understand their expectations for document review and best practices.

Getting Your CE Mark

Finally, it is recommended that you start the transition process as early as possible. While MDR transition has been delayed, waiting times to obtain CE markings are significant as Notified Body capacity is still a strong bottleneck in this process. In addition, your device may require significant changes and additional documentation that will require sufficient time for compilation and review.

Most manufacturers will need to take a hybrid approach to certifying their devices, depending on the type and variety of devices they already have, new products being introduced, the amount and quality of clinical evidence available, and the internal resources available to certify devices.

Can Nano-Lab help my Medical Device achieve Biocompatibility?

Understanding and preparing to comply with these new regulations is paramount. Nano-Lab experts will serve you in this process to understand your testing needs, get certified and safely deliver your products to patients in need.