New Study Examines if EU Regulations Are Stifling Medical 3D Printing

The medical 3D printing market has grown sharply in recent years. This includes in the EU, where the overall healthcare AM market is expected to grow at a CAGR of 15.4% until 2029. Unsurprising when you consider that the European Patent Office found last year that international patent families in 3D printing technologies had grown at an annual rate of 26.4% in the region, with nearly one-fifth of those done between 2001 and 2020 in the healthcare sector. But are there factors that are still slowing its growth?

New research from Dr. Marc Mimler, senior Lecture in Law at The City Law School, seems to suggest so. In the article “Core Legal Challenges for Medical 3D Printing in the EU,” Mimler along with other collaborators from different University hospitals as well as departments of mechanical engineering, sought to examine the EU legislation and case law, falling under Medical Device Regulation (MDR), on issues related to pre-market approval and post-market liability for 3D printed devices. And the results seem to show that gray areas within this are indeed hindering the growth of medical 3D printing, with more work needed to be done to clarify issues.

The focus of the study is on pre-market and post-market regulations for 3D printed medical devices (image credits: Mimler et al.)

Are EU Regulations Hurting Medical 3D Printing Growth?

The results, as outlined in a press release from the City School, are divided based on pre- and post-market status. Looking at the pre-market regulations, the researchers focused on the EU’s ‘Custom Device Exemption’ which allows devices made per a written description by an authorized person to bypass requirements like CE marking. And though this would seem a positive for 3D printing, the fact that ‘patient-matched’ devices (which have been made for a specific patient) do not fall under this creates a gray area for 3D printed medical devices. Especially since this distinction is not in place for ‘mass-customized’ devices.