Medizinproduktbereich

Medizinproduktbereich is a term used in German-speaking healthcare and industry to refer to the sector and organizational area that deals with Medizinprodukte – devices and equipment used for diagnosis, treatment, monitoring or alleviation of disease in humans. It encompasses development, production, procurement, distribution, installation, maintenance, calibration, repair and disposal of medical devices, as well as the management of related information systems and safety processes within healthcare facilities.

In the European Union, medical devices are governed by the Medical Device Regulation MDR (Verordnung (EU) 2017/745) and the In Vitro Diagnostic Regulation IVDR. Devices require conformity assessment and CE marking; manufacturers carry out risk management, clinical evaluation, and post-market surveillance. Nationally, Germany transposes these rules through the Medizinproduktgesetz (MPG). Notified bodies perform conformity assessments. Operators such as hospitals are responsible for proper device selection, installation, maintenance, user training, and incident reporting.

Devices are classified by risk (Class I, IIa, IIb, III; implants higher risk). Lifecycle activities include risk management according to ISO 14971, quality management per ISO 13485, and periodic safety updates.

In healthcare institutions the Medizinproduktbereich includes asset management, calibration labs, sterile services, and IT infrastructure for medical technology. It interacts with clinical departments, procurement, biomedical engineering, and infection control.

Current developments include increased digitalization, cybersecurity, data interoperability (HL7/FHIR), and remote monitoring; there is a growing emphasis on post-market surveillance and supplier qualification.