Abstract
Safety represents a key aspect in the context of 3D-printed MD, especially given the spread of do-it-yourself practices in this domain. Many jurisdictions, including—as seen—the EU and the US, have coped with this aspect through the implementation of ad hoc regulations for custom-made MD, which normally provide for some exemptions from the regulatory requirements usually applicable to standard MD.
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Notes
- 1.
IMDRF—International Medical Device Regulators Forum, “Personalized Medical Devices - Regulatory Pathways”, 18 March 2020, Chap. 6, Custom-made Medical Devices.
- 2.
Article 10 (9) of the MDR.
- 3.
Annex XIII—Section 2 of the MDR.
- 4.
Annex XIII—Section 1 of the MDR.
- 5.
Part B of Annex XIV to the MDR.
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Teresi, M. (2022). Safety and Quality in 3D Printing in the Clinical Context. In: Di Rosa, L. (eds) 3D Printing in Plastic Reconstructive and Aesthetic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-031-10558-6_14
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DOI: https://doi.org/10.1007/978-3-031-10558-6_14
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