More and more medical devices are tailored to the specific anatomy of the patient. Which makes sense! Why settle for a size S, M, L or XL implant, when the implant can be tailor-made? These custom-made devices are exempt from CE marking, but they still need to be safe and effective.
Custom-made devices (as a product) cannot (yet) be CE-marked, so make sure to validate the process instead of the product. Although the final product is always (slightly) different, the process to design and manufacture is always the same!
Also, the MDR requires manufacturers (art. 10) including in-hospital 3D labs to implement a Quality Management System (QMS) and although it doesn’t specify what kind of QMS, you have to minimally cover the MDR requirements for a QMS.
For this, you can use the Waveland compliance management system.
For larger manufacturers, a QMS according to ISO13485 makes the most sense.
A fully digital Quality Management System is the most powerful and accessible. But don’t forget that the MDR has additional requirement besides the requirements in ISO13485! For custom-made devices, those requirements are translated to understandable policies and actions in this online MDR Management System.
QasE3D can help you to deliver high quality and compliant (3D printed) custom-made devices, following Annex XIII of the MDR and assist in the implementation of an easy-to-use, digital QMS.