Before considering the requirements for custom-made medical devices, it is necessary to define which specific medical devices fall into this category. Custom-made medical devices are those specifically designed for a particular patient, taking into account their unique characteristics and needs, based on a written prescription from a physician. These can include individual prostheses, orthoses, implants, hearing aids, and other devices made to individual orders.
Before delving into the requirements of the Technical Regulation, it is important to address a key concept that will be encountered throughout this article – the concept of technical documentation. The Technical Regulation regarding medical devices does not provide a direct definition of “technical documentation” but includes requirements for its content. In summary, technical documentation for a medical device is a set of documents that includes information about the design, manufacture, properties, quality control procedures, safety of use, and other technical aspects related to the specific medical device.
The main regulatory document that defines the requirements for custom-made medical devices is the Technical Regulation No. 753 concerning medical devices. The requirements of this regulation include:
Design and Manufacture: Devices must be designed and manufactured to be safe and effective for the patient, using safe and biocompatible materials.
Labeling and Identification: Custom devices must be clearly labeled and identified for correct use and traceability. In addition to other information, the labeling must include the mark “medical device, custom-made.”
Technical Documentation: The manufacturer must prepare and maintain up-to-date technical documentation for the medical device, including the results of conducted tests, preclinical and clinical evaluations, and a risk management file.
Statement on Medical Devices of Special Purpose: For each custom-made medical device released, the manufacturer must prepare a declaration that includes information about the device, its characteristics, the production location, details of the prescribing physician, and confirmation that the medical device meets the requirements set out in Annex 1 to Technical Regulation No. 753.
To ensure compliance with Annex 1 of Technical Regulation No. 753, the manufacturer forms a Checklist for compliance with Annex 1, which includes information on all tests conducted by the manufacturer and references to other parts of the technical documentation for the medical device, as well as the standards according to which tests were conducted or specific parts of the technical documentation were compiled.
It is considered that the requirements for custom-made medical devices are not as stringent as for standard medical devices, but this is not true. Any established requirements that have not been fully met must be accompanied by a justified explanation. If full compliance with Annex 1 is possible, it must be achieved. Special attention should be paid to the biocompatibility of materials that come into contact with the human body and the operational characteristics declared by the manufacturer.
Technical Regulation No. 753 concerning medical devices sets requirements for the safe and effective use of individual medical devices. Compliance with these requirements ensures high quality and safety of medical devices tailored to the unique needs of each patient. Therefore, it is important to consider all aspects of the effectiveness and safety of the medical device before delivering it to the patient.
