- Customer Information IVDR, (165.0kB)
On May 26, 2022, the transition period from the In Vitro Diagnostics Directive (IVDD; Directive 98/79/EC) to the In Vitro Diagnostics Regulation (IVDR; Regulation (EU) 2017|746) will end. For this, MetaSystems is preparing CE certification according to IVDR for the new software versions Ikaros 6.3 and Metafer 4.3.
- MetaSystems Company Profile, (952.7kB)
- Material Safety Data Sheet (MSDS)
- Instructions for Use (IFU)
- Manufacturer Certificates
- Certificate ISO 13485:2016 and EN ISO 13485:2016 (Instruments), (449.7kB)
- Certificate ISO 13485:2003 and EN ISO 13485:2012 (Probes), (452.4kB)
- Certificate ISO 13485:2016 (MetaSystems USA), (439.1kB)
- Certificate of Registration: MDSAP, (421.9kB)
- FAQ on CE Mark and ISO Certificate for MetaSystems Imaging Products, (131.0kB)
- Declaration of Conformity Statements (CE)
- Reference Customer Form, (74.4kB)
- Reference Customer Form (Chinese), (186.8kB)
- Certificate: Commitment to Sustainability (DE), (584.0kB)
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