On December 1, 2023, the Director of Med Quality, Vladislav Kasianenko, participated in an event regarding the regulation of custom-made medical devices. He delivered a report on the importance of technical documentation for custom-made medical devices.
In his report, Vladislav emphasized the importance of technical documentation for custom-made medical devices, such as prosthetics, orthoses, 3D-designed products, and other assistive rehabilitation aids, to confirm compliance with the requirements of Technical Regulation No. 753 on medical devices.
To successfully meet the established requirements, a manufacturer of rehabilitation technical aids, custom implants, or other medical devices must prepare a number of documents:
- Description of the product, including its modifications, with drawings and explanations
- Risk analysis results (risk management file)
- List of applicable standards
- Results of conducted tests (preclinical evaluation)
- Clinical evaluation results
- Labeling and instructions for use
Vladislav also noted that for all manufacturers of custom medical devices, it is important to prepare a Declaration, which must be completed for each individual medical device released to the market. The Declaration must include information about the product, the manufacturer’s address, information about the doctor, and the characteristics of the product according to the doctor’s prescription. Additionally, the Declaration must contain information (declaration) that the medical device meets the requirements of Annex 1 to the Technical Regulation.
In conclusion, the director highlighted the desire of manufacturers to follow applicable regulatory requirements and improve the quality of their products. Thanks to this, the market for medical devices—prosthetics, orthoses, wheelchairs, 3D-printed implants, and other custom-made products—is developing, and Med Quality is pleased to assist all market operators in this regard.
