What is a medical device?

"Medical device" is a broad collective term for instruments, apparatus, equipment, software, implants or other objects that are used for medical purposes on humans and fulfill certain medical purposes alone or in combination. The range extends from simple bandages to complex high-tech devices. The definition is based on the intended use of the product to prevent, detect, treat or alleviate human health problems. The standards for the safety and performance of medical devices in the European Union are set out in the European Medical Device Regulation (EU) 2017/745 (MDR) and in Germany in the implementation of the Medical Device Law Implementation Act (MPDG), which supplements it. In-vitro diagnostics (EU) 2017/746 (In-vitro Diagnostics Regulation, IVDR) are used to examine samples taken from humans.  

The essential requirements ensure that medical devices are designed and manufactured in such a way that they are safe and effective without endangering the health and safety of patients or users. Clinical investigations are an important part of verifying the performance and safety of medical devices before they are placed on the market or to further demonstrate their effectiveness and safety after they have been placed on the market.