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
18:30 – Reception
REGISTRATION
By e-mail to info@sitem-insel.ch until March 1, 2019
PRESENTATIONS
190306 MDR SP - Andrea Heiland.pdf
190306 MDR SP - Stefan Lehner.pdf
190306 MDR SP - Monika Okories.pdf
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.
