Category - custom-made devices

medicaldeviceslegal

More on 3D printing (and biofabrication)

On 16 July I had the honor to give a lecture about Legal and Regulatory Aspects of 3D Printing (and biofabricaton) in the Focus on Life Sciences Summerschool program of University Medical Centre Utrecht, the Netherlands university hospital that made the headlines with a complete cranial replacement that was 3D printed. Partly old, partly new The […]

medicaldeviceslegal

3D printing of custom medical devices under future EU law

Lately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical devices – which is well on its way with more and more companies joining the fray. With companies like Siemens and GE investing […]