sitem-insel AG

2/19 MDR Support Panel: OBL, hazardous substances, combination products, and software

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DATE

June 17, 2019

PLACE

University of Bern
Main Building
Kuppelraum
Hochschulstrasse 4
3012 Bern

REGISTRATION

By e-mail to info@sitem-insel.ch until June 13, 2019

ADMISSION

Free admission

Own-brand-labeler (OBL), manufactures using hazardous substances, manufacturers of combination products or software developers will face many new challenges with the new MDR. Find out what you need to pay attention to in your products.


PROGRAM

16:30 – Admission

17:00 – Presentations and panel discussion

  • Consultant/Notified Body (tba)
  • Consultant/Notified Body (tba)
  • 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.