Regulatory Responsibility Statement

3Dresyns® supplies photopolymer resins as raw materials. 3Dresyns® resins are not finished medical devices and are not certified medical devices.

The legal manufacturer of the finished device is solely responsible for:

• device classification and intended use definition,
• selection of appropriate materials and manufacturing processes,
• validation of the complete workflow (printing, cleaning, post-curing, finishing, final cleaning),
• risk management, biological evaluation and determination of suitability for prolonged skin contact,
• regulatory compliance and certification of the finished device in the target market.

Device-level compliance, including conformity with applicable regulations and standards (for example, EU MDR 2017/745 and the ISO 10993 biological evaluation framework), must be established by the legal manufacturer based on their validated process and technical documentation.

Any material documentation, guidance, or supporting information provided by 3Dresyns® is generated under defined reference conditions and is intended to support customers’ assessments. Deviations in printer settings, geometry, cleaning chemistry, post-curing strategy (light and/or thermal), finishing operations, or final cleaning may alter conversion and the extractables/leachables profile. The legal manufacturer must determine whether additional verification or testing is required for the finished device.