10/2/2023 0 Comments Stand alone phone dialer app![]() It also provides guidance on the likely classification of the device. The guidance is intended to help developers of software and apps in navigating the regulatory system so they are aware of the procedures that they need to follow in order to affix a CE mark. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance to help identify the health apps which are medical devices. Standalone software and apps that meet the definition of a medical device are required to be CE marked in accordance with the EU regulatory requirements in order to ensure they are safe to use and perform in the intended manner. ![]() ![]() The use of medical device applications (apps) is growing for healthcare management in hospitals and the community, in social care settings and as an element of personal wellness and fitness monitoring.
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