Regulatory Information

The Medical edition of the Materialise Mimics® Innovation Suite currently consists of the following software components: Materialise Mimics® Medical version 23.0 and Materialise 3-matic® Medical version 15.0 (released 2020). Mimics® Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics® Medical is also intended for measuring and treatment planning. The Mimics® Medical output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics® Medical should be used in conjunction with expert clinical judgement. 3-matic® Medical is intended for use as software for computer-assisted design and manufacturing of medical exo- and endo-prostheses, patient-specific medical and dental/orthodontic accessories and dental restorations.


The Materialise Mimics® Innovation Suite currently consists of the following software components: Materialise Mimics® version 23.0 and Materialise 3-matic® version 15.0 (released 2020). Materialise Mimics and Materialise 3-matic are not medical devices.
Mimics® Medical and 3-matic® Medical are CE-marked products.


The below list of 3D printers has been validated for use with Mimics Medical for the creation of diagnostics 3D models. Please refer to the Mimics Medical user manual for additional instructions on good manufacturing practices for medical models. Other printers may be used with Mimics Medical, however, these have not been validated by Materialise for the creation of diagnostic 3D printed models.
 

Technology Manufacturer Model Material Applications
SLS EOS P730 PA2201 Orthopedic, Maxillofacial, Cardiovascular
Vat Polymerization Formlabs Form 2 Clear FLGGPCL02 Orthopedic, Maxillofacial, Cardiovascular
Vat Polymerization Formlabs Form 3/3B Grey V4 FLGPGR04
Clear V4 FLGPGR04
White V4 FLGPWH04
Orthopedic, Maxillofacial, Cardiovascular
PolyJet Stratasys Connex2 500  VeroWhite Orthopedic, Maxillofacial, Cardiovascular
PolyJet Stratasys J750/J735 Agilus, VeroBlackPlus, VeroClear, VeroCyan, VeroGrey, VeroMagenta, VeroPureWhite, VeroYellow Orthopedic, Maxillofacial, Cardiovascular
PolyJet Stratasys Objet30 Prime MED610 Orthopedic, Maxillofacial, Cardiovascular
Material Extrusion  Ultimaker 5S PLA Orthopedic, Maxillofacial, Cardiovascular
Multi Jet Fusion HP MJF 580 HP 3D HR CB PA 12 Orthopedic, Maxillofacial, Cardiovascular

Materialise medical device software may not be available in all markets because product availability is subject to the regulatory and/ or medical practices in individual markets. In countries where no regulatory registration is obtained of Mimics and/or 3-matic Medical, a research version is available. Please contact your Materialise representative if you have questions about the availability of Materialise medical device software in your area.

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