Rethinking the regulation of digital contraception under the medical devices regime

Contraceptives are vital healthcare for women and people with wombs. Recently, there has been a rise in the use of ‘digital contraceptives’, type ‘femtech’ software available download on app stores which require data input order to make predictions about users’ fertility. Digital contraceptives, when marketed as such, fall within definition ‘medical device’ under authority Medical Devices Regulations 2002 ‘medium-risk’ device. However, not all femtech may be used contraception is captured by this framework. In article it argued that regulatory category into digital contraceptives have placed medical devices regime (a) unduly limited scope, (b) insufficiently stringent protect users, considering grave life-changing effects technology can if things go wrong, (c) ill-conceived response affects large sections population. It suggested here broader context contraceptive sits (i.e. general market) key understanding blindness occurring comes some other forms fertility-related femtech. As fact ‘high risk’ should reclassified such.