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
31 August 2022
09.30 – 12.30 h

Sorell Hotel Ador
Laupenstrasse 15
3001 Bern

Tasks & obligations of a CH-REP and a PRRC

With the introduction of the revised MedDO, medical devices may only be imported into Switzerland if a Swiss authorised representative (CH-REP) is appointed for each product group and access to a responsible person (PRRC) has been organised. To date, more than 500 CH-REPs have registered as economic operators with Swissmedic. Two experts, Simon Heusler (AXXOS AG) and Beni Hirt (Decomplix AG), who are acting as CH-REP will present their views on the tasks and obligations, 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 – procedure for onboarding, mandates with manufacturers, liability insurance, Swissmedic inspections
→ Beni Hirt, Decomplix AG
10.10 – 10.30 h
Topic 2 – due dilligance, check of regulatory requirements (tech. doc, labelling, SPP etc.), vigilance, access to PRRC
→ Simon Heusler, AXXOS AG
10.30 – 10.45 h
Break
10.45 – 11.00 h
Preparation for workshop
→ Beni Hirt, Decomplix AG and Simon Heusler, AXXOS AG
11.00 – 11.45 h
Workshop concerning most urgent topics
Participants
11.45 – 12.15 h
Presentation of workshop results
→ 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

Doris Loretan

Project Manager

Fairs & Finance

+41 31 330 97 79

E-Mail

supported by