The certification of 3D resins as being medical devices can cause Health & Safety concerns since affixing CE marking (and certifications) to non-conforming products, such as 3D resins used for making medical devices is considered as "placing on the market unsafe non-conforming products or products to which the CE marking has been affixed falsely or in a misleading manner". For more info read: CE marking.
Chemicals, the ingredients or raw materials of 3D resins, are continuously analysed and reclasiffied from their safety properties. Updates of risk and hazard evaluations and findings evidence that often previously classified "safe" chemicals, may cause new discovered risks and hazards to humans and to the environment.
3Dresyns aims to replace any new reclassified "unsafe" chemicals with safer alternatives. Unfortunately, existing medical certifications are not covered by these updates since updates of chemical classification regulations are not linked to medical certifications, compromising the safety to humans and to the environment. In practice, certified resins as being medical devices, cannot be chemically modified, nor updated with safer raw materials.
This is becoming a health and safety issue since certifications, due to the high cost involved in getting them, cannot ensure that the safest raw materials are always used, nor consider the need for adapting formulations with safer chemicals, or for replacing nasty reclassified chemicals with less dangerous chemicals to humans and to the environment.
There is a large number of "certified" resins and devices which have become outdated, since they were placed on the market years ago, which have not been updated with new findings on the risks and hazards that they pose to human health and the environment.
There is a need to revise and update the risk and hazard classification of certified resins and devices, in coordination with the reclassification of their raw materials to protect humans and the environment.
Since reclassification of the risks and hazards of chemicals is a continuous ongoing international task, fixed outdated resin and medical certifications can cause more problems than benefits for humans and to the environment.
3Dresyns is continuously revising the risks and hazards of their raw materials and making new improved versions of their products with the safest ingredients to ensure maximum safety without compromising technical performance.
Reclassification of chemicals with increased toxicity is taken into account as a top priority in our research, which is focused in developing safer versions of our products to minimize their risks and hazards.
There are few examples in the 3D printing industry, where reclassification of some specific chemicals have considered them dangerous to humans, such in this example with hazard statement H361: suspected of damaging fertility or the unborn child. This specific chemical years ago was not suspected of damaging fertility or the unborn child, but later scientific evidence concluded that it is suspected of damaging fertility or the unborn child. Unfortunately, the different international regulations for biomedical certifications have not taken into account, nor synchronised, chemical classifications with biomedical certifications. Nowadays, unfortunately few certified resins and medical devices still use this type and similar unsafe chemicals.
3D resins are raw materials, not certified medical devices. Certification of 3D resins as being medical devices, besides misleading may cause potential health and safety concerns, since certified products cannot be updated when reclassification of their constituents considers them dangerous to humans and to environment.
The existing biomedical regulations are missing coordination with the international agencies responsible for classification of chemicals, such as REACH (EC 1907/2006), for ensuring maximum safety of biomedical devices and their update with safer constituents when reclassification confirms their increased toxicity.
Medical device manufacturers which spent high economical resources for certifying their products, have their compositions and production processes blocked, unless they pay again for the certification costs.
Similarly, 3D resin suppliers which misleadingly certified their resins as medical devices, have also "blocked" their compositions, without any possibility to adapt them to new reclassification updates related to increased toxicity of their raw materials. Unfortunately, due to the high costs involved, often obsolete unsafe certified resins extend their life cycle to amortice their certification costs, compromising safety, besides being a misleading marketing practice as clearly highlighted in the EU regulation on product requirements and market surveillance where indicates that it is forbidden to affix the CE marking (including certification) to products for which EU specifications do not exist or do not require the affixing of CE marking (or certification): "placing on the market unsafe non-conforming products to which the CE marking has been affixed falsely or in a misleading manner.”