Medical devices

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.

Knowledge Database

The A-to-Z database provides information on each pathogen, the most common infections that it triggers, its main transmission paths and recommendations on disinfection. In the glossary, you will find explanations of infection control terms. Search now!

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