sitem-insel AG

With the new MDR, the clinical evidence requirements for Class IIb and III products are increasing substantially. Find out how you can generate this evidence efficiently.

PROGRAM

16:30 – Admission

17:00 – Presentations and panel discussion

• Andrea Heiland, Morgan Sindall Professional Services AG
• Dr. Stefan Lehner, TÜV SÜD Product Service GmbH
• Monika Okories, Stryker GmbH
• Peter Studer, Swiss Medtech
• Rudolf Blankart, sitem-insel AG

18:30 – Reception

REGISTRATION

By e-mail to info@sitem-insel.ch until March 1, 2019 ​

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.