The arguments in your original article are correct. Prostheses, like 3D printed dental parts, are custom but still must meet the requirements for the EU MDR (MDD at the time) and ISO 13485. What counterarguments were used to avoid doing so? Giving away the parts for free, therefore not "placing on the market"?
Honestly I don't remember - especially it was my wife taking to Krzysztof. And yeah, I know I was right in principle, this is why the article remained on website. It is more of an anecdote...
The arguments in your original article are correct. Prostheses, like 3D printed dental parts, are custom but still must meet the requirements for the EU MDR (MDD at the time) and ISO 13485. What counterarguments were used to avoid doing so? Giving away the parts for free, therefore not "placing on the market"?
Honestly I don't remember - especially it was my wife taking to Krzysztof. And yeah, I know I was right in principle, this is why the article remained on website. It is more of an anecdote...