MHRA’s Guidance for Software as a Medical Device (including Apps)

The British MHRA (Medicines and Healthcare Products Regulatory Agency) has published a guidance for developers of “software as a medical device”  = “stand-alone software”. The text also expressly addresses “apps”. Get the details here.

http://www.gmp-compliance.org/enews_4445_MHRA-s-Guidance-for-Software-as-a-Medical-Device–including-Apps-_8308,8394,9058,9051,Z-COVM_n.html

Whereas in the pharmaceutical business software plays a role in the manufacture of products, it can also act as two parts in the medical device business – one in the manufacture of a device and one as a medical device as such – i.e. software as a medical device. The British Health Authority – MHRA – has published a current guidance on software as a medical device, also called stand-alone software, intended for developers of such software. This guidance also addresses the increasingly encountered topic “apps”. The text doesn’t cover software that is part of a medical device, e.g. software that controls a CT scanner.

The guidance itself is very short and divided into 6 main chapters:

• Introduction
• Key points and existing…