What is a medical device?

"Medical device" is a broad collective term for instruments, apparatus, appliances, software, implants or other objects that are used for medical purposes on humans and fulfil certain medical purposes alone or in combination.

The range of medical devices extends from simple bandages to complex high-tech appliances.

The definition is based on the intended use of the device to prevent, detect, treat or alleviate human health problems (in accordance with Article 2 (1) of Regulation (EU) 2017/745 (MDR)). The main intended action in or on the human body is not intended to be achieved by pharmacological, immunological or metabolic means. However, its mode of action can be supported by such agents.

Regulation

The standards for the safety and performance of medical devices in the European Union are set out in the European Medical Device Regulation (MDR). In-vitro diagnostics (EU) 2017/746 (In-vitro Diagnostics Regulation, IVDR) are used to analyse samples taken from humans. The Medical Devices Law Implementation Act (MPDG) supplements this definition for the German legal area. ISO 14155 specifies requirements for good clinical practice for the planning, conduct, recording and reporting of human clinical investigations to evaluate the safety or performance of medical devices.

The essential requirements ensure that medical devices are designed and manufactured in such a way that they are safe and effective without jeopardising 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 prove their effectiveness and safety after they have been placed on the market.

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