Materialise Obtains CE Marking Certification for Multiple Personalized Medical Devices


CATEGORY: Manufacturers and Distributors BRAND: Materialise

The company expects that the CE marking will enhance accessibility for personalized devices to become even more readily available. 

Materialise, a 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.


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.  


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.

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