U.K. regulator MHRA updates guidelines on medical app requirements

The U.K. regulatory body MHRA recently updated its guidelines for what health and medical applications should be subject to medical device oversight.

The updated guidelines cover applications that collect data from a person or device, such as blood glucose, and those that analyze and interpret data to make a diagnosis, prescribe medicine or suggest treatments, according to a report from PMLive.

“We live in an increasingly digital world, both healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health. Where apps or stand-alone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations,” MHRA director of medical devices John Wilkinson said, according to a PMLive report.

Applications that are defined as medical devices in the U.K., as well as the E.U., must have CE Mark approval to prove they are up to the designated regulations.

The MHRA’s guidelines reinforced that apps that provide incorrect diagnoses or provide inappropriate prescriptions could have severe and potentially life-threatening consequences, according to the report.

“Patient safety is our priority. We continue to encourage people to report any safety or performance issues involving medical devices, including apps, to MHRA via our Yellow Card Scheme online,” Wilkinson said in prepared remarks.

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