A medical device is a product intended by the manufacturer for use in humans and intended to fulfill one or more medical purposes. In this context, medical devices must be clearly distinguished from drugs, since medical devices do not achieve their main effect pharmacologically, immunologically or metabolically.
Medical devices are very diverse and can perform a variety of different functions. For example, they are used to diagnose or monitor and treat disease or injury. They can also be used to compensate for disabilities or alter anatomy. These include:
- Medical supplies (e.g., wound dressings, syringes).
- Medical supplies for people with disabilities (e.g., wheelchairs)
- Medical devices (e.g., X-ray machines, ultrasound machines)
- Active implants (e.g. pacemakers)
- Non-active implants (e.g. joint implants, bone screws)
- Medical software (e.g., software to assess the risk of trisomy 21)
- Medical laboratory diagnostics (e.g., HIV tests, pregnancy tests)
- Medical laboratory equipment (e.g. laboratory automats)
Information for manufacturers and authorized representatives
Information for importers and distributors
Incident reporting for users and physicians
Incident reporting for manufacturers and authorized representatives
Last updated: 31.12.2021