mdr Experience Day

The MDR Experience Days offer all interested parties the opportunity to meet with their peers and ad-dress relevant regulatory issues in a workshop. The event runs under the motto «From Industry for In-dustry», 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 ASDI and for medtech companies based in the canton of Solothurn. 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
6 September 2022
09.30 – 12.30 h

Hochschule Luzern
Technik & Architektur

Conference room D218
Technikumstrasse 21
6048 Horw

Site plan

First experiences with MDR product certification

As required by the MDR, all MDD/AIMD certificates will need to be updated before 26 May 2024. To date, only 1’000 out of 25’000 certificates have been cleared by the Notified Bodies (NB) under MDR. Timing is becoming critical because of the high workload for industry and NB in the remaining less than two years. In addition, the requirements for the contents of the technical documentation and for audits during the conformity assessment procedure have also sharply risen. Two experts, Jasminka Roth (The Tao of Excellence) and Ivano Oliveri (1Med), who have helped companies organize the transition from MDD to MDR will present their experiences, 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 – 09.50 h
Welcome and introduction, recording of most urgent questions/topics 
→ Daniel Delfosse, Swiss Medtech
09.50 – 10.10 h
Topic 1 – selected acc. input of participants
→ Jasminka Roth, The Tao of Excellence
10.10 – 10.30 h
Topic 2 – selected acc. input of participants
→ Ivano Oliveri, 1MED SA
10.30 – 10.45 h
Break
10.45 – 11.00 h
Preparation for workshop
→ Jasminka Roth, The Tao of Excellence and Ivano Oliveri, 1MED SA
11:00 – 11:45 h
Workshop concerning most urgent topics
Participants
11.45 – 12.15 h
Presentation of workshop results
→ Participants
11.15 – 12.30 h
Q&A Session
→ All
12.30 h
End of Event
from 12.30 h
Optional lunch (included)

Moderation

Dr. Daniel Delfosse

Vice Director

Head of Regulation & Innovation

+41 31 330 97 74

E-Mail

Organisation

Angela D’Aranno

Project Manager

+41 31 330 97 70

E-Mail

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