sitem-insel AG

3/18 Swiss MDR/IVDR Forum: Clinical data collection and reclassifications

The third Swiss MDR/IVDR Forum will explain for which products you need clinical data and how you can obtain them: What information is required to obtain an adequate clinical evaluation? What requirements do they have to meet?


16.30 Uhr – Admission

17.00 Uhr – Presentations and panel discussion

  • Martin Tettke, Berlin Cert GmbH
  • Dr. Ulrich Hofer, ISS AG
  • Dr. Diana Khabipova, VDI Technologiezentrum GmbH
  • Dr. Ela Bingel-Erlenmeyer, Geistlich Pharma AG
  • Peter Studer, Swiss Medtech
  • Rudolf Blankart, sitem-insel AG

18.30 Uhr – Reception


The new regulation of MDR/IVDR

With the adoption of new EU legislation on medical devices (MDR) and in-vitro diagnostics (IVDR), the European Union aims to significantly improve patient safety by improving risk assessment, market surveillance and transparency. In Switzerland, this leads to changes in the legal framework and has a direct impact on Swiss manufacturers, suppliers, importers, authorities, hospitals and patients.

These changes lead to a significant additional effort for all market participants, who have to implement the new requirements within very short deadlines in compliance with the law. The challenges are not only the short-term provision of new financial resources, but also the long-term development of personnel and know-how, including in the areas of quality management systems, clinical data acquisition, and post-market monitoring.


Concept of the Swiss MDR/IVDR Forum

The Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) and the industry association SWISS MEDTECH have been following legislative activities in Switzerland and the EU for several years and are actively working on solutions for small and medium-sized enterprises. For this reason, they jointly launched the Swiss MDR/IVDR Forum, in which the exchange of knowledge between authorities, consulting and manufacturing companies as well as other market participants is to be actively promoted at an early stage.