Updated guidance helps identify health apps which are medical devices
The Medicines and Healthcare products Regulatory Agency has issued updated guidance to help identify which health apps and software are medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance to help identify which health apps and software are medical devices, in vitro diagnostic devices and/or active implantable medical devices.
The interactive pdf helps developers and manufacturers ensure they are abiding by regulatory requirements, through assisting in the identification of products that require a CE mark. The guidance further includes information on the main aspects of classification and the CE marking process, as well as responsibilities for reporting and correcting when things change or go wrong.
The guidance also helps users of health apps or software devices identify whether they are using a medical device, how to identify a CE mark (ensuring the product is fit for purpose and safe to use) and how to report any problems that may arise.
