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All reports

All KCE reports are available in Dutch, French and English under several formats. Form and language of the reports

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Responsible use of high-risk medical devices: the example of 3D printed medical devices

KCE Reports 297 (2018) 3D printing is generating increased interest in the medical sector, namely in orthopaedics and dentistry, but there is no evidence that 3D-printed implants are as effective or safe as “classical” products. Yet they can currently be used without restrictions by doctors, even when they are “at high risk” (that is, more often than not, implantable).

https://kce.fgov.be/en/responsible-use-of-high-risk-medical-devices-the-example-of-3d-printed-medical-devices
Towards a guided and phased introduction of high-risk medical devices in Belgium

KCE Reports 249 (2015)

https://kce.fgov.be/en/towards-a-guided-and-phased-introduction-of-high-risk-medical-devices-in-belgium
The pre-market clinical evaluation of innovative high-risk medical devices

KCE Reports 158 (2011)

https://kce.fgov.be/en/the-pre-market-clinical-evaluation-of-innovative-high-risk-medical-devices