Crafting an intended purpose in the context of Software as a Medical Device (SaMD)
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
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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 바카라 사이트渟tate of the art바카라 사이트�, which includes creating documents to support this claim of safety. However, generating this safety documentation and defining 바카라 사이트渟tate of the art바카라 사이트� 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 바카라 사이트渟tate of the art바카라 사이트�, 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).
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