Imagine that you break your arm and it heals back together incorrectly, making it difficult to perform simple, everyday tasks. Wouldn’t it be wonderful if your surgeon could use medical imaging data from your arm, make a 3D virtual model and test multiple approaches to figure out the best way to fix it? With 3D visualization software, this is possible. What about going one step further and your surgeon making surgical guides so he/she would know exactly where to cut and drill your bone, and use implants and plates designed to fit your unique anatomy? 3D Printing can make this happen.
3D Printing software and services have drastically grown over the past few years in the medical sector, particularly when it comes to surgical planning software and patient-specific medical devices.
Patient-specific guides by Materialise
More patients have benefited from 3D Printing software and solutions as more medical centers have adopted this technology. However, with this advancement comes the flipside, which is that regulatory bodies face the challenge to make this technology available while maintaining patient safety standards.
This is why we advocate for dedicated regulation when it comes to medical devices so that it can continue to grow consistently and safely in the years to come.
Regulatory Obstacles along the Road…
This lack of regulation for 3D-printed, patient-specific medical devices can be seen in the current version of the EU’s regulatory framework. The EU has been working for many years on an update to the Medical Devices Directive. This proposed legislation has many noble attributes in addition to overcoming the flaws and gaps of the existing Medical Devices Directive, such as supporting technology and science innovation while simultaneously strengthening patient safety. This is something that we at Materialise fully support.
This lack of regulation for 3D-printed, patient-specific medical devices can be seen in the current version of the EU’s regulatory framework
However, as a 3D Printing company that manufactures medical devices, we fear that the current version of the draft Regulation lacks some depth and nuances which are mandatory to safeguard safe usage of 3D Printing technology and, thus, enable its increasing prevalence in medicine. 3D-printed medical devices, such as the ones produced by Materialise, fall in the category of “custom-made medical devices”, a category that also contains devices such as orthopaedic insoles. Regulatory rules for orthopaedic insoles should be different from rules for 3D-printed surgical guides, implants and plates, since the latter will require more stringent quality requirements. For this reason, our opinion is that the very broad “custom-made medical devices” category does not accurately address the needs and potential risks of using 3D Printing to design, produce and use patient-specific medical devices.
Giving a Home to 3D-Printed, Patient-Specific Medical Devices in the Medical Devices Regulation
The EU Medical Devices Regulation aims to contribute to better and more personalized healthcare. The 3D Printing technology is an excellent tool to help reach this goal. However, in order to build and maintain confidence in this technology, it is mandatory that legislators impose appropriate quality standards and requirements. Each device is designed and manufactured based on a patient’s medical image data, which ensures a perfect fit with his/her unique anatomy. As a result, each device is different, which makes it impossible to sample the devices during a quality inspection. This means that their manufacturing process must implement the appropriate quality requirements. The latter must be translated into a legal requirement imposed on the manufacturers of these 3D-printed, patient-specific medical devices. A standard regulatory environment along with harmonized regulatory supervision and verification throughout the EU would not only allow the industry to develop in a consistent manner (i.e. a safe use of 3D Printing for medical devices), but it would also increase the level of public health in a way where patient safety is guaranteed.
Wilfried Vancraen, Materialise, Chief Executive Officer