On February 3, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced new guidance on Digital Mental Health Technologies (DMHT) due to the increasing use of mental health apps, AI-based assessments, virtual reality therapies, and other digital mental health technologies. This new guidance is aimed at manufacturers.
The guidance document helps manufacturers identify the specific characteristics of DMHTs and determine whether they are considered Software as a Medical Device (SaMD). If they are classified as SaMD, the document also assists in determining the appropriate classification.
If the device is intended for medical purposes and the product’s functionality is considered complex, DMHT will be regulated as a SaMD and must meet the requirements set forth by medical device regulations. Additionally, it is necessary to demonstrate the safety and effectiveness of the product in accordance with recognized standards.
The key points of the guidance are as follows:
1) Device Characterisation
- The classification of DMHT primarily depends on the intended purpose and functionality.
- If the product is designed solely for general well-bing, it does not require medical device regulation.
- If the product is intended for diagnosing or treating mental health conditions, it is considered a medical device and must comply with medical device regulatory requirements. (For example, AI-based chatbots providing mental health assessments, virtual reality exposure therapy tools, apps providing Cognitive Behavioral Therapy (CBT) modules, etc.)
2) Determining qualification as SaMD
- Whether a DMHT qualifies as SaMD is determined based on the intended purpose and functionality of the device as stated in the label, Instructions for Use(IFU), promotional materials (e.g., website, social media, and advertisements), and technical documentation.
- The determination of SaMD status can also be assessed by evaluating the general user’s understanding and monitoring how the product is actually used.
3) Determining regulatory classification
- If the DMHT is classified as SaMD, the risk classification must be determined.
- Classification rules vary according to the UK MDR(which is developing a new framework for SaMD), EU MDD, and EU MDR, and the rule to follow depends on where and when the DMHT is launched in the market.
- Based on the level of risk, the product may be classified into Class I, Class IIa, Class IIb, or Class III.
Please refer to the attached document below.
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