Regulatory Deficits in Medical Devices

In the European Union (EU), requirements for placing medical devices on the market are defined in directives and their national implementation. The process of obtaining a CE-mark lacks transparency. Product testing is neither required during the CE-marking process nor afterwards, so that it is unclear whether the requirements for a CE-mark are still fulfilled by the medical devices on the market. In Germany, the Federal Institute for Drugs and Medical Devices reviews, in principle, the sustained quality of medical devices on the market and their compliance with EU directives, and it is responsible for incident reports related to medical devices. However, the reporting procedure lacks transparency, and end-users have no information about the number of incidents reported or related patient risks. In medical laboratories, the internal and external quality assurance is defined by the guideline of the Federal Medical Association about quality assurance for analyses in medical laboratories (Rili-BA"K). Depending on the specific analyte, trueness of measurement methods cannot always be determined. This lack of trueness is especially relevant if measurement methods, e. g., for glucose, are used off-label for primary diagnosis because they provide higher treatment efficiency. For some analytes, the Rili-BA"K, e. g., HbA1c, specifies acceptance criteria that could impair clinical relevance of measurements, because the criteria are not restrictive enough. We see the need to take action to reduce regulatory deficiencies regarding diabetes technologies. More transparent procedures when placing medical devices on the market but also in the quality control after market introduction could decrease patient risks.