Regulatory Responsibilities for Medical and Dental 3D Printing (Materials vs Devices)
This page defines the regulatory and responsibility framework applicable to the use of photopolymer 3D resins in medical, dental and orthodontic contexts.
3Dresyns® supplies photopolymer materials as raw materials and provides technical documentation and Instructions for Use (IFU). The transformation of materials into finished parts intended for medical use is performed by the user and falls under the responsibility of the device manufacturer.
Raw materials are not finished medical devices
Photopolymer 3D resins are raw materials. A finished medical or dental device is defined by its intended medical use, final geometry, validated manufacturing process, and applicable regulatory compliance.
A resin cannot be considered a finished medical device by itself. Claims and labels must be interpreted within the correct scope of what is being supplied and what is being manufactured.
Responsibility of the device manufacturer
The manufacturer of the final printed part is responsible for ensuring that the finished device is safe, effective and compliant for its intended use.
This responsibility typically includes:
- defining intended use and risk classification
- validating the full manufacturing process
- controlling printing and post-processing conditions
- performing biological evaluation and risk management
- maintaining traceability, documentation and change control
Material suppliers may provide data and guidance, but they do not replace the manufacturer’s obligations for device validation and regulatory compliance.
Process dependence and why results are not universal
In photopolymer printing, final performance is process-dependent. Mechanical properties, surface chemistry and biological response can change with printer technology, exposure strategy, build orientation, washing and post-curing conditions.
For this reason, performance data must be interpreted as typical behavior under reference configurations. End users must validate results under their own workflows.
“Certified resins” versus certified devices
Confusion may arise when raw materials are promoted using terminology that resembles device-level certification.
Device certification and regulatory clearance apply to the finished device and the validated process used to manufacture it. Material-level statements cannot replace device-level compliance requirements.
Using “material certifications” as a substitute for proper device validation may create false confidence and can increase compliance risk for manufacturers.
Quality management and ISO topics in context
Quality management systems are essential for reliable manufacturing, especially for medical and dental devices.
However, the presence or absence of a specific ISO certification at the raw-material supplier level does not by itself certify the final device or guarantee user compliance. What matters is whether the device manufacturer applies a suitable QMS, validates the full workflow and maintains traceability and controls consistent with the intended medical application.
Role of IFUs and qualified workflows
Instructions for Use define qualified workflows and reference conditions designed to support reliable printing outcomes. IFUs are critical because deviations in washing and post-curing can affect surface chemistry, extractables, mechanical performance and safety margins.
IFUs do not replace device validation. They provide a controlled basis for reproducible processing and documentation.
Transparency and responsible communication
3Dresyns is committed to transparent communication. Statements regarding compliance, safety or biocompatibility must remain within their validated scope and must not be generalized beyond the reference workflows and intended application context.
Governing principle
3Dresyns supplies photopolymer materials as raw materials. Finished medical or dental devices are defined by intended use, final geometry and validated manufacturing workflows. Device manufacturers remain responsible for validation, regulatory compliance, documentation and traceability under their specific conditions.