The Belgian Health Care Knowledge (KCE) released report of health technology assessment for high-risk 3D printed medical devices

In January, the Belgian Health Care Knowledge (KCE) published report of health technology assessment that was dedicated to evaluation of innovative high-risk 3D printed medical devices.

Development of recommendations in relation to reimbursement for 3D printed medical devices was not the goal of the study. The aim of the current report was to describe framework for managed practice and use of high-risk 3D printed medical devices. Scope of analysis did not include 3D printed products incorporating biomaterials which may be qualified as medicines, xenogeneic cell therapy preparations, 3D printed medicines and 3D bioprinting (3D fabrication technology involving biological tissues, organs and cells for medical and biotechnology applications).

Report provides description of evidence concerning efficacy, safety and cost-effectiveness of the 3D printed medical devices as well as legal issues (requirements to enter to the market, liability, data protection, patient’s rights, traceability, reimbursement, intellectual property rights).

See full-text report in English here.

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