Every new business model or product is always accompanied by specific legal implications that need to be considered at an early stage of development since this is a major factor of success. A business model or newly developed product will build trust with consumers when it has been developed both technically and legally. In medical treatments and in individual manufacturing of medical products, e.g. of implants, process chains have become more and more digitalised by using additive manufacturing, leading to alterations in supply and service relations.
On the one hand, sensitive patient data and printing files are being transferred among the parties involved – maybe even internationally to printing service providers based, for instance, in China. On the other hand, additive manufacturing can be used to produce, for instance, organs (3D bioprinting), customised drugs and pills or prostheses as well as models for operation plans in the area of medical, dental and orthopaedic technology, leading, however, to numerous legal implications. Beside the questions of who is owning rights to (technical) data or the protection of intellectual property, it is substantial to be compliant to data protection laws that apply to the personal data provided. Taking into account data and IT security is therefore of major importance. In practice, it is also highly important to clarify who of the parties involved will be liable, i.e. general practitioners or medical doctors, CAD designers, printing service providers or suppliers of material. In addition, one must consider specific regulations of medical law, such as the new regulation on medical devices passed by the European Parliament in May 2017.