Erik Vollebregt, an Amsterdam-based Life Sciences and IP lawyer and founder of the law firm Axon Lawyers, has reflected at length about the future of the European Union’s medical regulatory system as it relates to revolutions taking place in 3D printing. Erik is highlighting the fact that, in a world of cheap, customizable 3D printed devices, the EU’s current and upcoming standards of regulations aren’t prepared for the changes taking place. The lawyer begins by explaining that current EU regulation of customized medical devices is very light and will continue to be so, quoting an official memorandum as such: “Manufacturers of medical devices for an individual patient, so called ‘custom-made devices’, must ensure that their devices are safe and perform as intended, but their regulatory burden remains low.” As it stands, according to his law blog, manufacturers of 3D printed medical devices may be left to regulate themselves, but that these manufacturers must consist of “professional users”, like “a doctor of medicine, a dental practitioner or any other professional user.” He explains that a big, vague group like this may be fine for regulating low risk items, like insoles, but that 3D printed orthopedic implants will need to face stronger regulatory control.…
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