Medical devices - existing regulatory regime
A medical device is an instrument, apparatus, appliance, software, material or other article that is used in the prevention, diagnosis or treatment of illness or disease, the alleviation of/compensation for a handicap or injury or the replacement of a physiological process or the control of conception. Some types of medical device, known as in-vitro diagnostic medical devices (IVDs), are also used to conduct in-vitro diagnostic tests. These are tests done on samples such as blood or tissue that have been taken from the human body. In-vitro diagnostics can detect diseases or other conditions and be used to monitor a person’s overall health.
	The MHRA, acting on behalf of the Secretary of State (as described in paragraphs 11 and 12) is the designated competent authority that regulates compliance with and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure device safety, quality and performance. It is also responsible for the post market surveillance and vigilance of medical devices on the UK market, working with Competent Authorities across the EU on safety considerations including where the device has not been certified by a UK Notified Body.
	Medical devices are regulated in the UK by the Medical Devices Regulations 2002 (SI 2002/618). These regulations provide definitions for medical devices (including IVDs), and place obligations on manufacturers to ensure that medical devices are safe and fit for their intended purpose. Some aspects of the General Product Safety Regulations 2005  (SI 2005/1803) apply to devices that are also consumer products.