Medical Devices and the next gen of Medical Devices
Not easy to define what is a medical device. One reason is the multitude and diversity of existing devices. Another is the growing number of products that are on the border between device and medication; for example, prefilled syringes with a drug and heparin coated to prevent blood clots catheters.
Several countries and organizations have developed various definitions of "medical device". As the trade of these devices has acquired a global dimension, it has increased the need for regulatory control and a single harmonized definition. In 2005, the Global Harmonization Task Force (GHTF or International Working Group for harmonization), an expert group established in 1992 jointly by the industry of medical devices and regulatory authorities approved a definition that reflects the multitude of ways and uses of medical devices and since then has achieved wide acceptance.
As defined by the GHTF, in short, is meant by "medical device" means any instrument, apparatus, implement, machine, implant, reactive in vitro or calibrator, software, material or similar or related product that fails the main effect sought in or on the human body by pharmacological, immunological or metabolic means and is intended for use in humans with some (s) of the following purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation or compensation for an injury
- Investigation, replacement, modification or support of the anatomy or of a physiological process
- Supporting or sustaining life
- Control of conception
- Disinfection of other medical devices
- Providing information for medical or diagnostic purposes by in vitro examination of samples taken from the human body.