The Medical Device Coordination Group (MDCG) has recently published helpful documents.
The Medical Device Coordination Group is a committee of experts required according to the MDR and IVDR.
We are looking at two documents in detail:
Die Infografik “Is your Software a Medical Device” zeigt sehr anschaulich mit einfachen Worten und unterstützt durch Piktogramme, wie ich ermitteln kann ob meine Software in den Geltungsbereich der MDR (Medical Device Regulation) oder IVDR (In Vitro Diagnostics Medical Devices) fällt.
The MDCG 2021-3 document “Questions and Answers on Custom-Made Devices” answers questions about custom-made devices and contains considerations on adaptable and patient-adapted medical devices according to the MDR.
Right at the beginning, the document gives a basic definition of a custom-made product. Mass produces products that are customised at a later stage are often mistakenly regarded as custom-made products. To make this separation clearer, helpful examples are given.
The frequently asked question of whether components or materials from custom-made products can be placed on the market as MDR-compliant medical devices separately from the actual medical device is pursued, as is dealing with the increasingly established branch of 3D printed products. Finally, it is summary is provided as to which obligations manufacturers of custom-made products have to consider according to the MDR. Take a look at this very helpful guideline, find further answers to your questions and feel free to contact us to define which tasks need to be done.
A general overview of the publications is available on the MDCG website.