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.

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