Materialise NV, a leading company in 3D technology solutions in the industrial and medical markets, announces it obtained the CE Marking Certification for most of its personalized orthopedic and craniomaxillofacial (CMF) solutions. This includes 3D-printed anatomical models and patient-matched surgical guides and implants. Materialise is a pioneer of personalized solutions, helping patients and surgeons in six continents with the production of over 350,000 personalized devices. The company became one of the first to acquire this kind of certification for a large, personalized, 3D-printed medical device portfolio. This certification will make the technology more accessible for surgeons.
The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made procedure, which requires a medical prescription for every device. This procedure guarantees the quality of the devices and the safety of the patients, but it brings administrative hurdles for production in greater quantities.
“When the European Medical Devices Directive came to place in 1993, the use of personalized devices was exceptional. In the last 30 years, we have advanced 3D planning and printing to scale this technology to a much larger audience. At Materialise, we are talking about thousands of devices delivered worldwide every year. Personalized devices are no longer the exception. This CE marking certification demonstrates that these personalized devices meet the same stringent quality requirements as regular devices, despite the challenges involved to make every device match the specific patient’s anatomy,” says Brigitte de Vet, Vice President and Managing Director of Materialise Medical.
The CE marking will also improve accessibility to make personalized devices more readily available. With the new process in place, surgeons won’t need to sign a prescription for the devices they order. It means less paperwork and more agility for pharmacists managing personalized devices within the hospital.
“The advantage of using personalized devices is that they add more predictability into the surgical setting and allow the treatment of any clinical condition, including the most challenging ones. Now having this CE marking for our larger portfolio will help bring these personalized devices to even more patients, removing some of the administrative constraints for our customers,” adds Brigitte.
Since its foundation in 1990, personalized solutions have been Materialise Medical’s core business. Personalization starts with planning, and the launch of Mimics software in 1992 has enabled accurate, 3D image-based engineering, forming the base of advanced digital planning solutions available today. Materialise was also the first company to introduce personalized 3D-printed solutions into the operation room with the surgical knee guides’ launch in 2007. The CMF personalized implant launch in 2009 introduced a breakthrough in design with a porous structure in titanium that allowed the reconstruction of missing bone segments.
This CE certification is another milestone in bringing even higher quality standards in personalized medicine. Although the CE marking is a European concept, the system is widely accepted as a proof of compliance in other markets. This certification joins other CE markings already acquired by Materialise on medical software solutions, such as the Mimics Innovation Suite and Mimics Enlight.