As part of the MHRA’s Software and AI as a Medical Device Change Programme, the MHRA has recently published guidance on crafting an Intended Purpose Statement for Software as a Medical Device (SaMD).

This new guidance was intended to assist SaMD (including standalone software and apps) manufacturers to meet their statutory obligations. It proposed to do this by setting out key considerations and issues to avoid when drafting an Intended Purpose Statement, and by explaining the benefits of having a clear and accurate Intended Purpose.

What is an Intended Purpose?

Intended Purpose is defined as the use for which the device is intended, according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.

Its key elements are described as the: structure and function of the device; intended population; intended user; and intended use environment. This new guidance helpfully explains each of these concepts and how they intercept with one another.

Why is having a clear and accurate Intended Purpose important?

Demonstrating medical device safety to the MHRA requires manufacturers to design, manufacture, test, and monitor their product to the “state of the art”. This includes the preparation of documents to support the safety claims. The Intended Purpose Statement forms an important component part of this safety documentation and is a prerequisite for successful navigation of the regulatory framework.

Moreover, having clarity in an Intended Purpose can also enhance a manufacturer’s dialogue with those in the supply chain, including with customers and more widely in the marketplace.

What level of detail is required in an Intended Purpose Statement?

The guidance states that manufacturers must decide what level of detail is appropriate for their overall Intended Purpose. This may depend on the state of the art, the literature review and wider research. Context is said to be key. However, where there is uncertainty as to the appropriate level of detail, the guidance indicates that greater specificity is generally a simpler and safer approach to take.

Key considerations to keep in mind whilst preparing the Intended Purpose Statement

The guidance also outlines a useful diagrammatical methodology for drafting an Intended Purpose Statement, using the key elements referenced above. Notably, this methodology is not only intended to apply to the early design phase of product development but also to the key phases of the product development lifecycle including the post-market phase (i.e. to act as a feedback loop to further inform the Intended Purpose).

Importantly, the guidance also emphasises that performance characteristics should be testable and that the evidence base must cover all aspects of the Intended Purpose and “reasonably generalise to cover the specified locations and uses”.

Issues to avoid when drafting a SaMD Intended Purpose Statement

The guidance sets out four of the most common issues that the MHRA comes across and provides explanatory examples for manufacturers to help them avoid making the same mistakes. The four most common issues are:

• A failure to define the Intended Purpose with sufficient specificity and detail, for example by not specifying how usage of the SaMD might differ across different groups of intended users;
• Failure to specify the different Intended Purposes of multi-purpose devices;
• “Function Creep” – for example where a SaMD starts out with a clear Intended Purpose, which then becomes unclear over time as additional functionality is added to the SaMD; and
• A failure to justify the Intended Purpose with clinical evidence.

Summary

In summary, this new guidance provides manufacturers with some assistance in drafting an Intended Purpose Statement, an understanding of the importance of an Intended Purpose through the life cycle of a SaMD, and the importance of supporting their claims with evidence. However, the onus is on manufacturers of SaMD to decide on the appropriate level of detail, which will depend on many factors, including the ‘state of the art’, the literature review and wider research.

For information on this topic, please contact your DLA Piper relationship partner or Poppy Williams at poppy.williams@dlapiper.com.