Use of fused deposit modeling for additive manufacturing in hospital facilities: European certification directives.

PURPOSE: The goal of this study was to identify current European Union regulations governing hospital-based use of fused deposit modeling (FDM), as implemented via desktop three-dimensional (3D) printers.

MATERIALS AND METHODS: Literature and Internet sources were screened, searching for official documents, regulations/legislation, and views of specialized attorneys or consultants regarding European regulations for 3D printing or additive manufacturing (AM) in a healthcare facility. A detailed review of the latest amendment (2016) of the European Parliament and Council legislation for medical devices and its classification was performed, which has regularly updated published guidelines for medical devices, that are classified by type and duration of patient contact. As expected, regulations increase in accordance with the level (I-III) of classification.

RESULTS: Custom-made medical devices are subject to different regulations than those controlling serially mass-produced items, as originally specified in 98/79/EC European Parliament and Council legislation (1993) and again recently amended (2016). Healthcare facilities undertaking in-house custom production are not obliged to fully follow the directives as stipulated, given an exception for this scenario (Article 4.4a, 98/79/EC).

CONCLUSION: Patient treatment and diagnosis with the aid of customized 3D printing in a healthcare facility can be performed without fully meeting the European Parliament and Council legislation if the materials used are ISO 10993 certified and article 4.4a applies.