All reports

KCE Reports 347C (2021) To obtain marketing authorisation for the European market, any new product must provide evidence of its quality, safety and efficacy. For high-risk medical devices (e.g. implants), the requirements are less strict.

KCE Reports 297C (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).