MetaSystems software and system products are classified as in vitro diagnostic medical devices (IVD) in the European Union in accordance with In Vitro Diagnostics Regulation (EU) 2017/746 or In Vitro Diagnostic Medical Device Directive 98/79/EC, respectively, and carry the CE label unless otherwise indicated. Use all MetaSystems IVD products only within the scope of their intended purpose.
MetaSystems products are used in many countries worldwide. Depending on the regulations of the respective country or region, some products may not be used for clinical diagnostics.
Some hardware components supplied by other manufacturers are not included in MetaSystems IVD products and are therefore not IVD medical devices.
MetaSystems software provides, among other functions, features to assist users with image processing. These include, but are not limited to, the use of machine and deep learning algorithms for pattern recognition. The output generated in this process should be regarded as preliminary suggestions and, in any case, mandatorily requires review and assessment by trained experts.
MetaSystems offers Customization Packages for application workflows that have been successfully implemented for customer labs using standard Metafer platform functionality. It is expected that they can be implemented for other customer labs using similar workflows and slide preparation procedures. If a Customization Package is purchased, MetaSystems product specialists will - based on their experience from other similar application cases - support the customer lab in adapting the Metafer software configuration to their needs. The performance of the solution will depend on the quality of the customer slides and the expertise of the users, MetaSystems cannot specify or guarantee any performance parameters. The validation of the solution for clinical use is the sole responsibility of the customer lab.
Please contact us for further information.