According to the Ministry of Social Policy order No. 1208 “On the Organization of Provision of Certain Categories of the Population with Technical and Other Rehabilitation Means”, technical rehabilitation means must be registered in the State Drug Service Register as medical devices with product codes according to ISO 9999. However, in addition to registration in the Register, there are a number of requirements that manufacturers of technical rehabilitation means (TRM) must comply with according to the Technical Regulation on Medical Devices No. 753.
Technical rehabilitation means are created to ease the life of patients, so they are often made individually. They include prosthetic limbs, orthoses, orthopedic shoes, insoles, and other aids aimed at restoring bodily functions after injuries or illnesses. The Technical Regulation has a separate definition and requirements for medical devices made to order.
It is worth starting with the definition of the term “medical device.” According to the Technical Regulation No. 753 on medical devices:
“Medical device – is any instrument, apparatus, device, software, material, or other article, used either alone or in combination (including software intended by the manufacturer for use specifically for diagnostic and/or therapeutic purposes and necessary for the proper functioning of the medical device), intended by the manufacturer for use for the purpose of providing diagnosis, prevention, monitoring, treatment, or alleviation of the course of a disease of a patient in case of illness, diagnosis, monitoring, treatment, alleviation of the patient’s condition in case of injury or disability or its compensation, investigation, replacement, modification or support of anatomy or physiological process, control of the fertilization process, and whose principal intended action in the human body or on the body is not achieved by pharmacological, immunological, or metabolic means, but such means may assist its functioning.”
Now it is important to consider what makes a medical device a custom-made product. The Technical Regulation includes the following concept: “…a custom-made medical device – any medical device, specifically manufactured in accordance with a written prescription from a physician or a person with an appropriate level of professional qualification, specifying the particular design characteristics of this medical device, intended solely for a particular user”.
Appendix 9 to Technical Regulation No. 753 contains requirements for technical rehabilitation means and other medical devices made to order. This appendix, as well as the requirements of Appendix 1, defines the necessity for manufacturers to comply with requirements regarding labeling, safety, material quality, and others to ensure high quality and safety of the product.
Since creating custom technical rehabilitation means allows for adaptation to the specific needs of each patient, contributing to more effective rehabilitation, the requirements for TRM are not as strict as for regular medical devices. However, there are still a number of requirements that every manufacturer of technical rehabilitation means must follow.
First of all, this is the availability of technical documentation, which includes a description of the device, methods of its production and control, as well as test results. Suppliers of components can usually provide confirmation of test results according to specific standards, such as maximum load and material break tests. However, since suppliers conducted these tests at their own expense, they are not always willing to share the results. Also, attention should be paid to parts of the device that directly contact the human body – these parts or the device as a whole need to undergo testing for compliance with ISO 10993 for biocompatibility. Therefore, before registering the device in the State Drug Service Register, it is necessary to ensure that all tests have been carried out and the technical documentation is complete.
In summary, the technical documentation for a medical device should contain:
- a description of the device and its modifications, including drawings, diagrams, and their explanations (including components)
- risk analysis results (risk management file)
- a list of applicable standards
- results of tests conducted (preclinical evaluation)
- results of clinical evaluation
- labeling and instructions for use
Also, keep in mind the Statement on Medical Devices for Special Purposes, which must be completed for each individual medical device released to the market. The statement must contain information about the device, the manufacturer’s address, information about the physician, and device characteristics according to the physician’s prescription. Additionally, the statement must include information (statement) that the medical device meets the requirements of Appendix 1 to the Technical Regulation. To this end, manufacturers prepare a checklist of compliance with the requirements of Appendix 1 to Technical Regulation No. 753 on medical devices, which includes information with references to conducted tests, labeling, instructions for use of the device, and other parts of the technical documentation.
General labeling requirements for medical devices for technical rehabilitation means, which are medical devices made to order, also include mandatory additional labeling: “custom-made medical device”, indicating that the device was made for a specific user.
Certainly, manufacturing custom medical devices is a complex but extremely important process that requires manufacturers to be responsible and adhere to high safety and quality standards. It is important to remember that manufacturers are obligated not only to be in the State Drug Service Register but also to comply with the requirements of Technical Regulation No. 753 to ensure the safety and quality of the product.
