Safety & regulatory

3Dresyns® materials are supplied as raw photopolymer materials, additives, auxiliaries or process materials for additive manufacturing workflows. They are not supplied as finished medical devices.

Regulatory approval, CE marking, device classification, final-use compliance and validation of any final part, device or product remain the responsibility of the legal manufacturer or end user.

3Dresyns® develops and supplies advanced materials for industrial, dental, biomedical research, prototyping and specialized additive manufacturing workflows. Regulatory status and suitability depend on the specific material, processing route, intended use and jurisdiction.

Customers are responsible for ensuring compliance with applicable regulatory requirements for their specific application, country, industry and final product classification.

For materials intended for biomedical, dental or biologically relevant workflows, biocompatibility-related information is provided where relevant and available.

This may include:

• Reference to applicable standards or testing frameworks
• Material-specific biological interaction considerations
• Research-use, workflow-use or application-specific positioning
• Post-processing and validation dependencies

Final biological safety, certification and regulatory approval of printed parts, components or devices remain the responsibility of the customer or legal manufacturer.

3Dresyns® applies internal quality and testing procedures appropriate to the development and supply of specialty photopolymer materials and additive manufacturing systems.

Quality-related information may include:

• Raw material control and traceability principles
• Internal testing and validation approaches
• Batch, version and formulation-control considerations
• Performance consistency and process-dependency interpretation

Detailed quality documentation may be provided upon request where appropriate and when compatible with confidentiality and internal data-management policies.

Safety Data Sheets are provided upon request in accordance with applicable chemical safety regulations and internal data-management policies.

This controlled access ensures:

• Correct document versioning
• Regulatory consistency
• Appropriate use of safety-related information
• Protection of confidential compositional information where applicable

Requests should specify the product or products concerned, intended application context and destination country where relevant.

The use of 3Dresyns® materials in regulated environments requires appropriate validation, testing, documentation and approval by the customer, end user or legal manufacturer.

3Dresyns® does not assume responsibility for regulatory approval of final parts, devices, packaging, components or products manufactured using its materials.

Where regulatory compliance is required, users must validate the complete workflow, including material version, printer or manufacturing technology, cleaning, curing, sterilization if applicable, aging, packaging, intended use and jurisdictional requirements.