Medical Devices as Disability Aids

Medical Devices as Disability Aids: An Additional Source of Revenue? Health insurance funds reimburse insured people for disability aids, and because disability aids are often also medical devices, this opens up a potential additional source of revenue for some...

Digital Health Applications Ordinance

Digital Health Applications Ordinance (DiGAV, Digitale-Gesundheitsanwendungen-Verordnung): What Manufacturers Should Know Tuesday, April 21, 2020 On April 17, 2020, the German Federal Ministry of Health (Bundesministerium für Gesundheit) presented the preliminary...

Regulatory Science

Regulatory Science: Europe is Flying Blind In German-speaking areas, regulatory science is rarely practiced systematically. And this failure creates problems for medical device manufacturers and harms both the health system and the region as a business location....

Health Care Facilities

Effects of the MDR and IVDR on health institutions such as clinics and other operators. 14 January 2020 The MDR and IVDR contain hundreds of requirements for the manufacturers of medical devices. But these requirements also affect the so-called health care...