3Dresyns conclusions about 3D Printing Medical Devices at the Point of

Key principle: under applicable regulatory frameworks, medical device manufacturers (not raw material suppliers) are responsible for the safety and quality of the medical devices they place on the market.

Point-of-care (PoC) 3D printing can enable rapid, personalized and agile production of medical devices. At the same time, PoC production raises critical questions about responsibility allocation, quality assurance and patient safety, especially when using photoreactive resins that require strict control of printing and post-processing to reduce uncured monomers, extractables and leachables.

Why this matters for photopolymer 3D printing

3D printing with photopolymer 3D resins can potentially cause severe health problems if printed medical devices are not fully polymerized and properly cleansed before use. Any residual monomers or other extractables/leachables may be released from the printed part if the workflow is not fully controlled.

Delegating production to third parties (or distributing responsibilities across multiple entities) can create ambiguity around:

who is legally responsible for the finished device,
who owns quality system obligations,
how process validation and traceability are assured.

3Dresyns concerns: liability clarity and “certified resin” confusion

3Dresyns is concerned about unclear allocation of legal liability between:

Health Care Facilities (HCF) (including dentists and orthodontists), and
the Medical Device Production System (MDPS) concept introduced for PoC 3D printing.

It is also a significant concern that so-called “certified” 3D resins may be treated as if they were medical devices as supplied, even when the certification does not include the full manufacturing system (printer, validated printing parameters, post-processing equipment, cleaning, post-curing, QA controls, etc.). Using “resin certification” as a substitute for certification/validation of the finished in-house printed medical device can increase patient risk and legal ambiguity.

Raw materials are not medical devices (core regulatory logic)

Raw materials (including 3D resins) used for additive or subtractive manufacturing are generally not medical devices, because regulating a raw material alone cannot ensure that the final manufactured device meets safety and performance requirements.

This can appear to contradict “real life” examples such as dental restorations and denture systems where reactive materials (including monomers such as methyl methacrylate, MMA) have historically been marketed within regulated dental workflows, despite being hazardous before polymerization (see background reading on MMA toxicity).

Additive vs subtractive manufacturing: different risk profiles

In general, subtractive workflows that mill a fully polymerized and pre-qualified disk tend to present a different risk profile than additive workflows based on photo-reactive resins, because additive workflows rely heavily on the user’s process capability to achieve full conversion and safe post-processing.

3Dresyns position: leaving the responsibility of fully curing and cleansing photoreactive resins to printer users—while relying on raw material “certifications”—can create high risk, because polymer conversion and residual monomer content inside the final device are process-dependent and beyond the direct control of resin suppliers.

Medical device manufacturers remain legally liable for the safety and quality of their in-house produced medical devices. For a detailed discussion of resin supplier responsibilities, see:

Responsibilities of manufacturers of 3D resins for medical uses

Reference documentation

FDA has published a dedicated discussion paper on PoC manufacturing:

Discussion Paper: 3D Printing Medical Devices at the Point of Care (FDA)

Key FDA regulatory references:

International regulatory background:

IMDRF: Personalized Medical Devices – Regulatory Pathways

Background reading (example):

Methyl methacrylate (MMA) toxicity background (Sigma/MilliporeSigma)

FDA discussion paper: practical summary for PoC 3D printing

FDA recognizes that PoC 3D printing may serve an important public health purpose and may enable rapid production of devices. FDA also notes that HCFs may have less experience with medical device regulatory frameworks than traditional manufacturers, yet PoC devices must still be:

high-quality,
fit for intended use,
not exposing patients to unreasonable risk of illness or injury.

Key oversight themes highlighted by FDA

Assuring devices 3D printed at the PoC are safe and effective
Assuring appropriate control of devices 3D printed at the PoC
Clarifying the responsible entity
PoC training and capabilities

What is an MDPS?

A Medical Device Production System (MDPS) is described as a collection of raw materials, software/digital files, main production equipment and post-processing equipment intended to be used by a healthcare provider/facility to produce a specific type of medical device at the point of care. The MDPS includes the device it is intended to produce.

What requirements apply to device manufacturers?

Finished device manufacturers (including entities that 3D print devices) are generally subject to relevant device regulations, including registration/listing obligations and quality system requirements, unless exempted.

Three PoC manufacturing scenarios discussed by FDA

Scenario 1: HCF uses an MDPS; the MDPS manufacturer assumes regulatory and manufacturing responsibilities; the HCF is the user of the MDPS.
Scenario 2: A traditional manufacturer operates on/near the HCF site; the HCF does not engage as a manufacturer.
Scenario 3: HCF assumes traditional manufacturer responsibilities; the HCF is responsible for applicable regulatory requirements.

Why capability and training matter

PoC facilities vary widely in equipment and experience. Because devices vary in complexity and risk, an HCF may be capable of producing some devices but not others. FDA highlights the importance of:

strong science and sensible clinical guidelines,
appropriate regulatory oversight,
stakeholder engagement, discussion and consensus-building,
quality standards (e.g., ISO 13485) and robust controls.

Five stages of 3D printing (useful QA framework)

Device design
Software workflow
Material control stage before manufacturing
Post-processing stage (removal, cleaning residues, annealing/heat-treating, post-machining, biocompatibility assessment, terminal sterilization/cleaning)
Validation after post-processing (process validation and acceptance activities)

IMDRF: key concepts relevant to PoC

The IMDRF framework reinforces that:

raw material regulation alone cannot ensure final device compliance, because additive/subtractive manufacture is multifactorial and process-dependent,
instructions provided by a raw material manufacturer cannot fully control all variables of manufacturing performed by end users.

Off-label use and responsibility shift

If an HCF uses an MDPS to produce a device outside the original manufacturer’s intended use, responsibility for that new intended use can shift to the HCF. If the HCF additionally markets/promotes the new intended use, it may be considered a manufacturer and relevant manufacturer requirements may apply.

“Materials” that can be medical devices

Some jurisdictions regulate specific “materials” as medical devices (example: dental restorative resins) where safety and performance assurance relies on validated instructions and controlled clinical workflows. This does not eliminate the need for correct processing or the manufacturer’s responsibility to validate performance and safety of the adapted/assembled device.

Practical implications

Do not equate resin claims/certificates with device certification. Finished device safety is workflow-dependent.
Clarify who is the responsible manufacturer in PoC models (HCF vs MDPS provider vs traditional manufacturer).
Implement a controlled, documented workflow across printing and post-processing, with traceability and validation appropriate to device risk.
Invest in capability and training, including process control, record keeping and verification testing.

3Dresyns conclusions about 3D Printing Medical Devices at the Point of Care