ABHI Position on the Repair and Maintenance of Medical Devices & IVDS
This document covers repair and maintenance of medical devices and IVDs. This is distinct from the placing on the market of a medical device or IVD that has been fully refurbished or remanufactured.
Many medical devices and IVDs are designed to be maintained and repaired so that the device continues to be capable of fulfilling its intended use throughout its whole lifecycle. Proper repair and maintenance of devices protects the safety of patients, device users and others. Where the legal manufacturer of the device intends the device to be repaired or maintained by the user or by a third party, the manufacturer will provide instructions and specify any components, tools or spare parts that must be used. Some repair or maintenance activities are not intended to be carried out by users or third parties. In this case, the manufacturer (or their nominated representative) is responsible for carrying out the repair or maintenance. Organisations who repair and maintain medical devices and IVDs are important to the functioning of healthcare in the UK.
Repair and maintenance in line with the legal manufacturer’s instructions and using tools, spare parts or components that meet the manufacturer's specification are not considered to be deviations from the manufacturer's instructions. Reporting of potential vigilance incidents is an important part of the regulations and helps to demonstrate patient safety. Third party repair and maintenance organisations can report vigilance incidents direct to the legal manufacturer for onward statutory reporting to competent authorities.
Where repair or maintenance is carried out not in line with the manufacturer's instructions or using tools, spare parts or components that do not meet the manufacturer’s specifications, however, this can potentially modify the device and may therefore need to apply the requirements of the relevant medical devices regulations. This might include taking legal liability for future issues and the need to report vigilance incidents to the competent authority.