sitem-insel AG

Reusable low-risk surgical medical devices now belong to the Ir (reusable) class. There is no transitional period for these products, so they must have undergone the new procedure by May 2020. This presents the industry with great challenges.

PROGRAM

16:30  – Admission

17:00 – Presentations and panel discussion

• Markus Wipf, Axxos GmbH
• Dr. Johannes König, TÜV SÜD AG
• Peter Studer, Swiss Medtech
• Rudolf Blankart, sitem-insel AG

18:30 – Reception

BACKGROUND

The adoption of the new EU legislation on medical devices (MDR) and in-vitro diagnostics (IVDR) has a direct impact on Swiss manufacturers, suppliers, importers, authorities, hospitals and patients. The changes lead to significant additional costs in an environment of high time pressure and uncertainty. In particular, regulatory issues are unresolved or unknown for many market participants.

The Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel) and the industry association Swiss Medtech have been pursuing legislative activities in Switzerland and the EU for several years. They actively work on solutions for small and medium-sized enterprises. To achieve pragmatic solutions, they host the MDR Readiness Day and the MDR Support Panel.

CONCEPT

During the MDR Readiness Day, topic-specific questions from representatives of SMEs will be dealt with, while consultants and Notified Bodies will take a stand on the questions in the MDR Support Panel and point out possible solutions.