# Crafting an intended purpose in the context of Software as a Medical Device (SaMD)

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/28a635bd-45f3-4c6f-b460-450f697a3bf6
Type: Guidance
Published: March 22, 2023

> This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the requirements for products classified as Software as a Medical Device (SaMD) under the UK medical devices regulations. While this document does not target a specific company or reference individual inspection dates, it serves as a broad directive for all legal manufacturers operating within the UK market. The primary focus is the necessity for manufacturers to demonstrate that their products' benefits outweigh potential risks by adhering to current state of the art standards throughout the design and manufacturing lifecycle. A central issue identified by the MHRA involves the submission of vague or insufficient intended purpose statements. Such inadequacies can lead to legal non-compliance and significant safety concerns, as they fail to accurately establish the product's risk level or the specific evidence required for safety verification. To rectify these issues, the MHRA requires manufacturers to develop highly specific intended purpose statements. These documents must clearly articulate what the software does, define the specific population intended to benefit, identify the authorized users, and specify the clinical or home environments where the product will be used. This initiative is part of the Software and AI as a Medical Device Change Programme, aimed at ensuring that regulatory requirements remain clear and that patient safety is prioritized as technology evolves.

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## Content

Plain English Summary Products classified as medical devices must demonstrate they meet the requirements of UK medical devices regulations. The purpose of these regulations is to ensure the benefits of a product outweighs the risks, so that UK citizens have access to safe and effective medical products. Demonstrating medical device safety to the MHRA requires the legal manufacturer to design, manufacture, test, and monitor their product to the “state of the art”, which includes creating documents to support this claim of safety. However, generating this safety documentation and defining “state of the art” can be complex and time-consuming. As part of this guidance, manufacturers must produce an intended purpose statement to specify what a product does, a description of the people it is designed to benefit, who should use it, and where it should be used. The intended purpose statement should have a high level of clarity and specificity, which, if written adequately, should assist with several subsequent requirements of the regulations. The intended purpose statement should provide the reader with an understanding of the appropriate “state of the art”, product risk level, and the evidence required to demonstrate the safety of the product. An inappropriate intended purpose statement can lead to non-compliance with the law and possible safety concerns. In this document we outline some common concerns with intended purpose statements and provide guidance on how to craft an appropriate intended purpose statement for Software as a Medical Device ( SaMD ). Software and AI as a Medical Device Change Programme Last year, the MHRA announced the Software and AI as a Medical Device Change Programme , a programme of work to ensure regulatory requirements for software and AI are clear and patients are protected.

## Attachments

- [Crafting an intended purpose in the context of software as a medical device (SaMD)](/government/publications/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd)