About Certification of biomedical devices and food and pharma packaging

3D-printed medical devices placed on the EU market fall within the scope of EU product legislation, including the EU Medical Device Regulation (MDR) 2017/745. As a result, the manufacturer of the finished device must ensure the product meets the applicable regulatory requirements before placing it on the market—typically including conformity assessment (as applicable), technical documentation, a declaration of conformity, and affixing the CE marking for the final device (when required).

3D resins are raw materials, not finished medical devices

Photopolymer 3D resins are photoreactive liquid raw materials. They polymerize (cure) under controlled light exposure during printing—typically layer by layer—to form a solid part with a defined geometry. Final device safety and performance depend on: resin selection, printer characteristics, exposure dose, cleaning, post-curing, post-processing, and quality controls implemented by the device manufacturer.

Why “CE-marked” or “certified” 3D resins can be misleading

In general, applying CE marking or presenting a resin as a “certified medical device” can be misleading, because liquid resins are not medical devices and do not represent the finished product placed on the market. The relevant legal and safety evaluation must be performed on the final manufactured device and its intended use.

For more context, see: CE marking and Health & Safety concerns of “certified” 3D resins.

EU market surveillance and product compliance rules also address false or misleading affixing of CE marking: EU regulation on product requirements and market surveillance.

Biocompatibility is process-dependent

Many photopolymer systems can exhibit cytotoxicity before printing and may still present risk after printing if processing is incomplete or not adequately controlled. Achieving the intended safety profile typically requires: validated printing parameters, adequate cleaning, sufficient post-curing, appropriate post-processing, and verification by quality controls.

For biomedical devices and food/pharma-contact applications, manufacturers should select low-risk raw materials and implement robust workflows to minimize the presence of extractables, leachables, residuals, and process contaminants in the finished part.

Published findings highlighting post-processing sensitivity

The literature includes examples where post-processed printed parts can still release leachables. For example:

• Are Biocompatible 3D Printer Resins Truly Safe?
• Formlabs dental resins Dental SG and LT Clear used in 3D printing technologies release ovo-toxic leachates

A broader review in orthodontics also discusses that biological effects can depend strongly on the specific resin and on whether a final surface treatment is performed: The Biological Effects of 3D Resins Used in Orthodontics: A Systematic Review .

Additionally, post-polymerization conditions can significantly affect the degree of conversion: Evaluation of dimensional accuracy and degree of polymerization of stereolithography photopolymer resin under different postpolymerization conditions .

For aligners, variability in monomer leaching has also been reported: Leaching from a 3D-printed aligner .

Responsibilities: resin supplier vs. device manufacturer

Biocompatibility and safety outcomes can fail due to (a) inadequate material design (e.g., use of higher-risk ingredients), and/or (b) inadequate processing and controls that leave residuals, leachables, extractables, or contaminants in the finished part.

• Resin suppliers are responsible for:
  • designing and producing materials using as safe and low-risk raw materials as feasible for the intended application scope
  • providing clear Instructions for Use (IFU) and processing recommendations
  • quality control of the supplied raw material (as a raw material), according to the supplier’s declared specifications
• Medical device / packaging manufacturers are responsible for:
  • selecting appropriate materials and auxiliaries for the intended use
  • validating the complete manufacturing process (printing, cleaning, post-curing, post-processing, sterilization where relevant)
  • implementing appropriate quality controls (including assessment and control of extractables/leachables as needed)
  • ensuring regulatory conformity, technical documentation, and (where applicable) certification/market access of the finished product

Quality and safety assurance: what typically matters most

Safety and performance depend on polymer conversion and process control. Key drivers include printer type and calibration, exposure dose and wavelength, cleaning chemistry and duration, post-curing method and total energy dose, and the overall manufacturing environment. These factors influence the risk of residuals, byproducts, impurities, and contaminants that could migrate from the finished device unless controlled.

Practical conclusion for manufacturers

• Use compliant raw materials for the intended use—avoid relying on “resin certification” as a substitute for device conformity.
• Use reliable, calibrated, well-maintained printing and post-processing equipment.
• Integrate and validate workflows under appropriate quality systems (e.g., GMP/QMS as applicable).
• Implement validated printing/cleaning/post-curing/post-processing protocols and relevant quality controls.
• Document evidence that the finished product meets the intended safety and performance requirements for its use.

Learn more

• What is a medical device?
• About FDA’s Technical Considerations for Additive Manufactured Medical Devices
• About 3D Printing Medical Devices at the Point of Care
• IFU for biocompatible resins
• Relevant device manufacturer certifications vs non relevant resin certifications