Scientific protocols and controls need to be designed and implemented properly to ensure that any potential leachables and extractables; unreacted monomers, byproducts, impurities, contaminants and residuals are avoided to the maximum degree, by using high purity biocompatible raw materials and by eliminating and extracting them from medical devices before commercialisation to reduce the risk of extraction and absorption by users during use. 3D resins and medical devices need to be carefully designed with the right raw materials and tuning additives to reduce and avoid their potential extraction and absorption during use.

Medical device manufacturers need to control and minimised the concentration of leachables and extractables by eliminating and extracting them before use, as well as control and maximise polymer conversion of their medical devices produced in their facilities to ensure maximum conversion from monomer to polymer, to say conversion from a photoreactive liquid 3D resin into a fully cured and "safe" biomedical device. Ensuring that medical devices are traded without any trapped unreacted monomers and any other sort of leachables and extractables is responsibility of medical device manufacturers since legally are and will always be responsible of the quality of their traded products.

Both, biocompatible 3D resins and medical devices need to be properly designed in tune with reliable printing setups and workflows to fully comply with the Quality requirements for the manufacturing of medical devices (Class I, IIa, IIb and III) or food packaging products. Not all the biocompatible resins, printers, post processing setups and controls meet the required minimum specifications for printing medical devices, or food packages, for passing certification standards.

Acknowledge that biocompatible 3D resin manufacturers supply photoreactive photopolymer 3D resins, not finished biomedical devices, consequently their certification as suppliers of medical devices is not legally valid as replacement of the certification required for medical device manufacturers.

Biocompatible 3D resins need to be compliant (not certified) and designed in accordance to the quality requirements relevant to the biomedical application for which were designed.  Their certification is not legally valid nor relevant, nor can be used by medical manufacturers as replacement of their own certifications, in accordance to the specific certification requirements by the regulatory authority of each country where their products will be traded.

Unfortunately, the use of non relevant certifications of raw materials suppliers is a common, confusing and perplexing misleading practice by some resin suppliers with the aim of gaining sales by promoting the validity of their certifications, as replacement of the legal responsibility of medical device manufacturers of having their own certifications, which legally are, and legally will always be, responsible for certifying their products, production processes, facilities and companies.