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.
He also wonders if 3D printed devices will be considered “customizable ‘standard’ medical devices” that will be subject to the same controls as mass produced, but individualized items. The EU’s regulatory amendment about mass-produced medical devices states:
However, mass-produced devices which need to be adapted to meet the specific requirements of a doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices…
As Erik sees it, in the realm of 3D printing a customized device, the process and materials will remain essentially the same and that the design of each device will only be changed a bit for each patient. For this reason, he’s unsure if 3D-printed medical devices will be considered “customizable ‘standard’ medical devices” whose regulation is through the “prescription” of a doctor or other medical professional.
So, Erik begins hashing out how the EU might be able to ensure the safety of the new technology in the medical field. He believes that high risk, invasive or implantable, 3D printed medical devices should be studied clinically, the way that any implantable medical device might in the EU. Just as a new insulin pump is put through clinical trials, so should implantable 3D-printed devices. He also suggests that the materials used to print a device might be regulated in the same way that other medical materials, explaining that “even if the input material is completely generic material, just like complete generic industrial gasses like oxygen must be licensed as medicinal products in a number of member states if they are to be used for medical purposes.”
While the regulation of medical devices may differ in countries outside of the EU, I’m sure that Erik’s insight will help lawmakers draft regulations the world over. And, especially when it comes to high risk fields like medicine, it will become increasingly important to understand how the technology might be regulated. As Erik concludes, “If this technology delivers on its promises – and all the signs point to that it will – it will very soon be an important regulatory item the medical devices regulation cannot afford to not have seriously considered.”