Is the EU Lagging Behind in 3D-Printed Medical Device Regulation?

Quite often here, we discuss the advances 3D printing is making in the medical sector. So, you may be surprised to learn that the European Union is lagging well behind other countries when it comes to regulation regarding 3D-printed devices made for medical use. At least, this is according to researchers at the German FH Münster University of Applied Sciences, who proclaim that governing bodies in other countries have less ambiguity in regulatory language used to govern the use of 3D-printed medical devices. Ambiguity in regulatory language can result in a stunted market and increased cost for businesses.

The EU’s regulation of 3D-printed medical devices is covered by the European Medical Device Regulation (MDR), which regulates the nearly 500,000 types of medical devices available on the EU market. The scrutiny around the EU’s regulations for 3D-printed medical devices has risen to attention due to an exception made in the ordinance for “mass-produced devices which need to be adapted to meet the specific requirements of any professional user.” Which effectively means, medical products produced using additive manufacturing processes will not be considered custom-made.

3D-printed medical device regulation is too ambiguous, according to German FH Münster University of Applied Sciences. (Photo Credit: Carl Campbell on Unsplash)

Regulation for 3D Printing Medical Devices

The largest claim being made by the FH Münster researchers is that a “medical device Q&A’ endorsed by the European Commission failed to clarify 3D printing’s role in the medical sector, and rather, made things more confusing. In the study that examines the regulatory language, the researchers uncovered conflicting statements specifically related to existing MDG regulations and the newly released Q & A “clarification” which now distinguishes between ‘patient-matched medical devices’ and ‘adaptable medical devices.’