Medical Device Claims & Intended Purpose
Manufacturers are required to clearly define the intended purpose of a medical device on its labeling and instructions for use. This statement must be explicit and precise, detailing the specific medical conditions or functions the device is designed to address. Utilizing the device beyond its stated intended purpose can lead to safety risks and regulatory non-compliance.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) emphasizes the importance of a well-crafted intended purpose statement, particularly for Software as a Medical Device (SaMD). An inappropriate statement can result in legal non-compliance and potential safety concerns.
Within the European Union, the Medical Device Regulation (MDR) defines ‘intended purpose’ as the use for which a device is intended, as specified by the manufacturer on the label, instructions for use, or promotional materials. This definition underscores the necessity for consistency across all documentation and marketing materials.
Any modification or expansion of a device’s intended purpose requires additional regulatory approval. Such changes may necessitate further clinical investigations to ensure the device’s safety and performance for the new application. Therefore, it is crucial for manufacturers to thoroughly evaluate and define the intended purpose before seeking initial regulatory approval.
Write an Intended Purpose for your SaMD
Download a sample of Intended Purpose Document here.
Further information on writing an intended purpose can be found here.
References
- Medicines and Healthcare products Regulatory Agency. (2023, March 22). Crafting an intended purpose in the context of software as a medical device (SaMD). Retrieved from https://www.gov.uk/government/publications/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd
