Quite often here we discuss the advancements of 3D printing in the medical industry. So, you might be surprised to learn that the European Union lags behind other countries when it comes to regulations regarding 3D printed devices for medical use. At least that’s what researchers at the German University of Applied Sciences FH Münster claim, claiming that governing bodies in other countries have less ambiguity in the regulatory language used to govern the use of medical devices. 3D printed. The ambiguity of regulatory language can lead to a market downturn and increased costs for businesses.

EU regulations on 3D printed medical devices are covered by the European Medical Device Regulation (MDR), which governs the nearly 500,000 types of medical devices available on the EU market. The scrutiny of EU regulations for 3D printed medical devices has drawn attention due to an exception made in the ordinance for “series devices which must be adapted to meet the specific requirements of any professional user.“This effectively means that medical products made using additive manufacturing processes will not be considered custom-made.

The regulation of 3D printed medical devices is too ambiguous, according to the German University of Applied Sciences FH Münster. (Photo credit: Carl Campbell on Unsplash)

Regulations for 3D printing of medical devices

The biggest claim made by researchers at FH Münster is that a European Commission-approved “Medical Device Q&A” failed to clarify the role of 3D printing in the medical sector, and instead rendered things more confused. In the study that examines regulatory language, researchers uncovered conflicting statements specifically related to existing MDG regulations and the recently published Q&A “clarification” that now distinguishes between “patient-friendly medical devices”. ”And“ adaptable medical devices ”.

Instead of “removing the ambiguity as hoped,” scientists say the document “increases uncertainty” and puts the EU’s medical industry in a position well below regulatory clarity governing 3D printing of medical devices in Australia and the United States. The study points out that many companies have yet to start implementing the new regulatory requirements, especially small businesses. Many companies face the hurdle of technical documentation, clinical evaluation, as well as post-market monitoring. As a result, 3D printing companies may face increased operating costs due to MDR, shrinking product portfolio, and reducing new product launches to market, which is essentially a bottleneck for innovation. You can read more about the regulatory research of the FH Münster team HERE.

EU regulations now distinguish between “patient-friendly medical devices” and “adaptable medical devices”. (Photo credit: ShapeShift 3D)

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Cover photo credit: National Cancer Institute