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Materialise Obtains CE Marking Certification for Multiple Personalized Medical Devices

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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 orthopaedic and cranio-maxillofacial (CMF) solutions. This includes 3D-printed anatomical models and patient-matched surgical guides and implants. Materialise is a pioneer and world leader 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.

Materialise has a legacy of adhering to the highest possible safety standards, and it is one of the first to have a full personalized portfolio CE certified. The company believes this kind of certification will help raise the industry bar to ensure patient safety and transparency on personalized devices’ production.

The CE marking will also improve accessibility to make personalized devices even 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.

About Materialise

Materialise incorporates more than three decades of 3D printing experience into a range of software solutions and 3D printing services, which together form the backbone of the 3D printing industry. Materialise’s open and flexible solutions enable players in a wide variety of industries, including healthcare, automotive, aerospace, art and design, and consumer goods, to build innovative 3D printing applications that aim to make the world a better and healthier place. Headquartered in Belgium, with branches worldwide, Materialise combines the largest group of software developers in the industry with one of the largest 3D printing facilities in the world.

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Adam Strömbergsson

Adam is a legal researcher and writer with a background in law and literature. Born in Montreal, Canada, he has spent the last decade in Ottawa, Canada, where he has worked in legislative affairs, law, and academia. Adam specializes in his pursuits, most recently in additive manufacturing. He is particularly interested in the coming international and national regulation of additive manufacturing. His past projects include a history of his alma mater, the University of Ottawa. He has also specialized in equity law and its relationship to judicial review. Adam’s current interest in additive manufacturing pairs with his knowledge of historical developments in higher education, copyright and intellectual property protections.

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