Materialise to enhance accessibility for Personalized 3D Printed Medical Devices with new CE Marking Certification

Image: Materialise

Making additive manufacturing more accessible for surgeons

Certification has always been mentioned as one of the hurdles that slow down the wide adoption of 3D printing – especially in a vital industry such as medical. Materialise NV just reached another milestone in its 3D printing journey by obtaining a CE Marking Certification.

The certification is available for most of its personalized orthopaedic and cranio-maxillofacial (CMF) solutions, which include 3D-printed anatomical models and patient-matched surgical guides and implants. 

With over 350,000 personalized devices produced worldwide, Materialise is one of the first to acquire this kind of certification for a large, personalized, 3D-printed medical device portfolio.

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 exceptionThis 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. 

What does it mean for surgeons?

The company explains that, 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,” concludes Brigitte.  

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