Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended purpose in the context of Software as a Medical Device (SaMD)" that provides detailed instructions on defining the intended purpose for Software as a Medical Device (SaMD).
The MHRA defines SaMD/Software as a Medical Device as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device".
Specifically, the document is intended for manufacturers of SaMDs, which include standalone software and apps. It explains the importance of clearly defining the intended use.
An intended purpose can be crafted at any point in the product life cycle by focusing on two key factors:
1) The key elements of an intended purpose statement
2) The level of specificity of these elements
To create an intended purpose, one must present as clearly and concisely as possible the facts about what a medical device is intended to be used for. In order to maintain clarity and conciseness, the statement must be backed up by detailed evidence and rationale, which must be documented elsewhere (such as in the clinical evaluation report).
In order to successfully navigate the regulatory requirements for medical devices, manufacturers must have a clear intended purpose, and the MHRA encourages manufacturers to make this information publicly available.
Click this LINK to know more about this guidance.
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