The German medical device market is part of the European market. Therefore, not only the European regulations apply here, but also the German regulations in addition. The changeover at European and German level regarding directives and regulations poses an additional challenge. The previous regulations MDD, MPG and the IVDD have been superseded. At European level, these have been replaced by the MDR (EU) 2017/745), which is supplemented by the German MPDG. The application of the IVDR (EU) 2017/746 instead of the IVDD is legally binding from 25 May 2022. As part of this changeover, manufacturers are also obliged to have medical devices already on the market recertified. However, the problem arises that the Notified Bodies have bottlenecks in personnel capacity due to the increased demand.
For more than ten years, NEMIUS, based in Germany, has been advising manufacturers on quality managements, risk managements, biocompatibility and technical documentation and supporting manufacturers on the approval of medical devices and in-vitro diagnostics. We know the market and are happy to support you in your project.
