Intended use

Users of medical devices, such as physiotherapists or doctors, must observe the intended use of medical devices for various reasons:

✅ Patient safety: The intended use of a medical device specifies the applications for which, and the conditions under which, the product can be used safely and effectively. Using medical devices outside their intended use may lead to an increased risk to patients, as the product may not have been tested or validated for that specific application.

✅ Liability: If a healthcare professional uses medical devices outside their intended use and thereby causes damage or injury, this may result in legal consequences and liability claims. Compliance with the intended use therefore also serves to protect users from potential liability risks.

✅ Effectiveness: The effectiveness of a medical device is generally tested and confirmed for its specific intended purpose. Using the product for other applications may mean that the expected therapeutic outcomes are not achieved and the treatment is ineffective.

✅ Regulatory requirements: Adherence to the intended purpose is a prerequisite for compliance with regulatory requirements such as Regulation (EU) 2017/745 on medical devices (MDR). The use of medical devices outside their intended purpose may contravene these regulations and result in legal consequences.

✅ Quality assurance and risk management: Adherence to the intended purpose of a medical device forms part of a comprehensive quality management system and risk management framework, which must be implemented by both the manufacturer and the user. Using a medical device in accordance with its intended purpose ensures that the risks associated with its use are appropriately assessed and controlled.

➡️ In summary, it is important for users of medical devices, such as physiotherapists or doctors, to adhere to the intended use of medical devices in order to ensure the safety and effectiveness of treatment, minimise liability risks and meet regulatory requirements.