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

 

On 22^nd March 2023, the UK Medicines and Healthcare Products Regulatory Agency – UK MHRA published a Guidance on defining the intended purpose for Software as a Medical Device (SaMD) to help SaMD manufacturers in meeting their statutory obligations. Here are some key points from the guidance:

 

• Products classified as medical devices must demonstrate that 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. Our experts are helping digital health innovators to navigate regulatory requirements.

Apart from creating the right intended purpose statement, we are helping manufacturers bring their products successfully to the market.

 

Take your first step and get on the right side of the law by complying with #RegulatoryAffairs

Speak to our experts by sending an email at grs@globalregulatoryservices.com

Complete guidance can be found at - https://www.gov.uk/government/publications/crafting-an-intended-purpose-in-the-context-of-software-as-a-medical-device-samd

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