In 2017, Germany has established Nationaler Arbeitskreis (NAKI) – the National Working Group for the Implementation of the new EU Regulations on Medical Devices (MDR) and In Vitro Diagnostics (IVDR). The group was created in order to set up a solid basis for the proper national implementation of new EU legislations.
Once the national implementation process began, the German Competent Authority, The Federal Ministry of Health, involved all the affected groups in a discussion platform. Among others, NAKI includes Federal Ministries of Health, Economy and Energy, Education and Research and Defense, the Federal Institute for Drugs and Medical Devices, the Paul Ehrlich Institute, the German Institute for Documentation and Information and Robert Koch Institute, manufacturers’ associations and the Association of Notified Bodies.
NAKI is supported by seven subgroups on the topics of transitional regulations, notified bodies, manufacturer’s obligations, market surveillance, classification and vigilance, clinical evaluation/clinical testing and preparation.
Each subgroup is identifying problems and questions in their scope. As most of the burning questions still must be clarified at a EU level, the aim is to contribute to the EU bodies with the results. The work of each subgroup may be found by clicking on the following link.
Regulatory Affairs Department
Obelis is regularly checking all the updates of the NAKI group, as well as all the novelties concerning the upcoming MDR on the EU level. If you are interested how the MDR is going to affect the German national market or any other national market, contact us with confidence!