Medizingerät

Medizingerät is a term used in German to describe devices intended for medical purposes, including diagnosing, monitoring, treating, or preventing disease or injury. The category encompasses a broad spectrum of tools and systems, from simple instruments such as thermometers and stethoscopes to complex equipment such as magnetic resonance imaging scanners, infusion pumps, implantable prostheses, and software used for clinical decision support. In many contexts the term overlaps with the European Union designation Medizinprodukt, which covers devices as well as accessories and related services.

Regulation and safety: In the EU, medical devices are governed by the Medical Device Regulation MDR 2017/745. Devices are assigned to risk classes (I, IIa, IIb, III) and require conformity assessment, Notified Body involvement for higher-risk devices, CE marking, and ongoing post-market surveillance. Manufacturers must implement quality management systems (often ISO 13485), perform clinical evaluations, and provide labeling and instructions for use. The EU also introduced a unique device identification system (UDI) to improve traceability. In Germany, the national framework is implemented through the Medical Devices Act (Medizinproduktegesetz, MPG) in harmony with EU rules.

Lifecycle and responsibility: The development and use of medizingeräte follows a lifecycle including design and risk management (ISO 14971), production, installation, maintenance, and end-of-life considerations. Post-market vigilance requires reporting of adverse events and recalls.

Impact and use: Medizingeräte underpin modern diagnosis, treatment, rehabilitation, and home care. Access and use are often regulated by prescription or professional supervision. Safety, reliability, interoperability, and user training are essential aspects of their deployment.

Examples: stethoscope, thermometer, glucose meter, electronic patient record software, MRI scanner, implantable joint, infusion pump, ventilator.