Regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with coronavirus (COVID-19)

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance regarding the classification of stand-alone software and applications as medical devices. Under this regulatory framework, software defined as instructions that process input data into output must obtain CE, CE UKNI, or UKCA marking if it meets the criteria for a medical device. This ensures the products are safe and function as intended by the manufacturer. Software categories likely requiring regulation include those used for diagnostic processes including artificial intelligence, chronic condition management such as diabetes or mental health, patient monitoring, and clinical decision support. Conversely, apps used strictly for recording patient details or general well-being without medical claims are generally exempt. Simple clinical calculators, like the Glasgow Coma Score, may also be exempt if their results are easily verifiable; however, complex calculators integrated into electronic health records usually require marking. Manufacturers and developers are required to assess their products against the full medical device definition and ensure compliance with marking standards. For specific inquiries, the MHRA provides a dedicated contact channel to assist with classification and safety requirements.