3D printing of medical devices is an advanced technology that allows for the creation of customized medical devices tailored to individual consumer needs. This technology already opens up many possibilities, including the production of prosthetics, orthopedic implants, surgical templates, and more.
According to the Technical Regulation No. 753 on medical devices, medical devices produced using 3D printing are considered custom-made medical devices. Before discussing regulatory requirements, it is important to understand the concept of a custom-made medical device as defined by Technical Regulation No. 753.
Thus, “…a custom-made medical device is any medical device specially made based on a written prescription from a physician or a person with appropriate professional qualifications, which specifies the particular design characteristics of the medical device intended for a specific patient. From this definition, it follows that a medical device is considered custom-made only if there is a corresponding prescription from a physician, which includes a diagnosis and the expected characteristics of the custom-made medical device.
Now, it is necessary to consider the regulatory aspects of the manufacturing process for medical devices using 3D printing technology. It is generally believed that if a medical device is custom-made, it is subject to fewer requirements than a regular medical device. While there is some truth to this statement, it often leads to ignoring other important requirements of the Technical Regulation. For example, according to Appendix 9 of Technical Regulation No. 753, manufacturers of custom-made devices must prepare a Declaration of Custom-Made Medical Devices for each custom-made medical device. The declaration must include information about the device, the manufacturer’s address, the physician’s name who issued the prescription, and the device characteristics according to the prescription. Additionally, the declaration must include a statement that the medical device complies with the requirements established in Appendix 1 of the Technical Regulation.
Appendix 1 requires manufacturers to conduct testing, risk analysis, clinical evaluation, labeling, and other measures to ensure the safety and effectiveness of the medical device for patients. It is also important to prepare technical documentation, which should be carefully considered before starting the production of medical devices.
First and foremost, the technical documentation should include a detailed description of the device and its possible modifications. Methods of production and control measures implemented during the manufacturing process must be specified. Special attention should be given to the description of suppliers and materials used for 3D printing. Since medical devices made using 3D printing technology are often implants and come into direct contact with the human body, materials must undergo appropriate biocompatibility testing according to the ISO 10993 standards. Usually, suppliers can provide test results, but since they conduct these tests at their own expense, they may not always be willing to share the results.
Also, since custom devices printed on 3D printers are designed and printed using software, it is necessary to ensure that no failures occur during the design and manufacturing process that could lead to the production of defective devices and harm the patient. Therefore, software suppliers must perform validation according to IEC 62366 standards and provide corresponding reports. If suppliers do not provide such documentation, the manufacturer must conduct the validation. This will ensure that the design and manufacturing process achieves the expected result—effectiveness and safety of the medical device for the patient.
Therefore, before manufacturing devices using 3D printing technology, it is essential to ensure that all tests are conducted and technical documentation is prepared. In summary, the technical documentation for a medical device should include:
- a description of the device and its modifications (examples for each type of work)
- risk analysis results (risk management file)
- a list of applicable standards
- results of conducted tests (preclinical evaluation)
- clinical evaluation results
- labeling (marking) and instructions for use
Special attention should be given to the labeling of devices made using 3D printing, as the Technical Regulation on custom-made medical devices requires additional labeling: “custom-made medical device”, as well as unique identification of each produced device, indicating that the device was made for a specific consumer. Therefore, significant attention should be paid to the labeling process during the design phase.
After completing the preparation of technical documentation, conducting necessary tests, and implementing a quality management system to control production, data about the medical device manufacturer and its types must be entered into the Register of Persons Responsible for Medical Devices on the State Service of Ukraine’s website. After that, production can proceed without any restrictions.
3D printing of medical devices opens new horizons in the development and production of custom medical devices for patient treatment. This technology allows for the creation of more accurate, effective, and personalized solutions for the medical field. However, it is important to remember the effectiveness and safety of the product for the end user and to follow regulatory requirements.
