mdr Experience Day

The MDR Experience Days offer all interested parties the opportunity to meet with their peers and address relevant regulatory issues in a workshop. The event runs under the motto «From Industry for Industry», is held in English, lasts from 9:30 a.m. to 12:30 p.m. and concludes with an optional lunch. It costs CHF 80 for members of Swiss Medtech and ASD as well as for members of SVDI. Non-members can register for a fee of CHF 180. Please note that the event is limited to 40 participants so that exchange between participants is encouraged.

MDR Experience Day
15 February 2023
09.30 – 12.30 h

HWZ Hochschule für Wirtschaft Zürich
Lagerstrasse 5
8021 Zurich

Task and obligations of a Swiss importer

With the introduction of the revised MedDO (Medical Device Ordinance), every distributor who imports a medical device automatically becomes a Swiss importer and must register at Swissmedic to obtain a CHRN number. To date, more than 1,500 Swiss importers have done so. Their tasks and obligations are set out in the Swiss MedDO but refer mostly to the European MDR (Medical Device Regulation) – despite the fact the Switzerland is now a third country to the EU. How can the distributers best fulfill their task? Two experts, Jasminka Roth (The Tao of Excellence) and Christoph Schär (QUNIQUE GmbH), will present their views, lead through the workshop and will also be happy to answer your questions. Please send us your most urgent questions already when registering.

Program

 

09.30 – 10.00 h
Welcome and introduction (CH as third country), recording of most urgent questions/topics 
→ Daniel Delfosse, Swiss Medtech
10.00 – 10.15 h
Topic 1 – Importer obligations MDR/IVDR 
→ Jasminka Roth, The Tao of Excellence
10.15 – 10.30 h
Topic 2 – MDR/IVDR vs MedDO/IvDO (Swiss finish) 
→ Christoph Schär, QUNIQUE GmbH
10.30 – 10.45 h
Break
10.45 – 11.00 h
Preparation for workshop
→ Jasminka Roth (The Tao of Excellence), Christoph Schär (QUNIQUE GmbH)
11:00 – 11:45 h
Workshop concerning most urgent topics
Participants
11.45 – 12.15 h
Presentation of workshop results
→ Participants
12:15 – 12:30 h
Q&A session
Participants
12.30 h
End of Event
from 12.30 h
Optional lunch (included)

Registration

+
+
Participation terms
Participation
Membership confirmation
Catering
Menu choice

Moderation

Dr. Daniel Delfosse

Head of Regulation & Innovation

Member of the Executive Board

+41 31 330 97 74

+41 79 308 80 76

E-Mail

Organisation

Angela D’Aranno

Project Manager

+41 31 330 97 70

E-Mail

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