Medical devices

They are intended for:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap
• Investigation, replacement or modification of the anatomy or of a physiological process
• Control of conception.

Medical devices have a wide scope of action, and some examples of medical devices include: contact lenses, hearing aids, pregnancy test, ECG device with heart rate monitor, glucose meter, thermometers, patches, blood pressure gauges, injection syringes with or without needle, surgical thread, defibrillators etc.

Medical devices are grouped according to the level of risk into:

1. Class I – medical devices with low risk for users
2. Class IIa – medical devices with medium risk for users
3. Class IIb – medical devices with high risk for users
4. Class III – medical devices with highest risk for users.

Compared to medicinal products, the difference is that a medical device does not achieve its action by pharmacological, immunological or metabolic means – it is achieved using physical methods (by mechanical means, physical barrier, substitution or support of the role of an organ or body function), while a medicinal product achievesits action by pharmacological, immunological or metabolic means.