Medical devices are no medicinal products, but are, in the narrower and broader sense, intended for human health as well. Art. 3 German Medical Device Directive (MPG) defines a medical device as e.g. instruments, dressings, implants. This also includes agents for disinfection of medical instruments and equipment such as endoscopes.
There are four medical devices classifications:
- Risk class I: Products with low risk potential, e.g. cleaners for medical devices or bandages.
- Risk class II a: Products with medium risk potential, e.g. disinfectants for medical devices (instrument disinfectants).
- Risk class II b: Products with increased risk potential, e.g. disinfectants for contact lenses.
- Risk class III: Products with high risk potential, e.g. artificial heart valves or medical devices that contain a drug.
For medical devices to be marketable in the European Union they have to carry the CE Mark to show that they meet European guidelines.