MDR & IVDR Online ConferenCe
Instead of the MDR & IVDR Conference, which was postponed to 25 March 2021 due to the coronavirus pandemic, an online event will take place in the morning of 15 September 2020. This will enable us to meet the high demand for information on the MDR, the Mutual Recognition Agreement between Switzerland and the European Union and the new national Medical Devices Ordinance (MepV).
MDR & IVDR Online Conference
15 September 2020
09.00 – 12.15 h
MDR and more – a Swiss Perspective
Swiss Medtech will use this framework to unite representatives from the industry, authorities and Notified Bodies. We will highlight and discuss the topic from various perspectives during two plenary sessions and a breakout session. Take this opportunity to find out information and participate in the «Questions & Answers» chat.
09.00 – 09.10 h: Welcome and organisation of the event
Hosted by Swiss Medtech
09.10 – 10.00 h: Plenary session 1: The MRA between Switzerland and the EU
Where do we stand today? Christophe Perritaz (SECO)
Possible scenarios for the Swiss Medtech industry. Daniel Delfosse (Swiss Medtech)
How does it affect a typical Swiss Medtech company? Simon Michel (Ypsomed)
How does it affect a large multinational Medtech company? Roman Iselin (J&J)
What do you need to do? Bernhard Bichsel (ISS)
Questions & Answers
10.00 – 11.00 h: Breakout session
- Topic 1: How to manage your EAR (European authorised representative).
Taking up the EC-REP obligation progressively, viewpoint of a SME. Cloé Houriet (Fabrinal SA)
The legal framework to establish and manage your EC-REP. Challenges and pitfalls. Michael Maier (Medidee Services AG)
What should you do? Markus Wipf (Axxos GmbH)
- Topic 2: Will all distributors need a Swiss representative?
How likely is this scenario or can it be avoided? Daniel Delfosse (Swiss Medtech)
What would it mean for a Swiss distributor with products from many different manufacturers? Harald Schatzl (Mediwar)
Viewpoint of 2nd distributor, tbd (Synmedic)
What should you do now? Jasminka Roth (Tao of Excellence)
- Topic 3: How to be(come) a preferred supplier for legal manufacturers.
What do we expect from our suppliers? Monika Okories (Stryker)
What do we do to meet the expectations? Raphael Laubscher (Laubscher Präzision)
Complete focus on supply. tbd (Jabil)
What should you do? Barbara Polek (SFL Ltd.)
- Topic 4: IVDR only one year behind MDR. Is there enough time?
The main challenges for an IVD company. Kira Meyerovich (BD)
What should you do? Silvia Anghel (Medidee)
Viewpoint of an IVDR-designated Notified Body, Heike Möhlig-Zuttermeister (BSI)
11.00 – 11.50 h: Plenary session 2: The new Swiss MepV
A substantial revision of the Swiss law to remain equivalent with the EU law. Daniel Albrecht (BAG)
Interaction with the EU authority network, Markus Wälti (Swissmedic)
The view of a Swiss Notified Body. Daniel Taddeo (SQS)
How does it affect the Swiss Medtech industry? Daniel Delfosse (Swiss Medtech)
Questions & Answers
11.50 – 12.15 h: Plenary discussion
moderated by Heiko Visarius (VISARTIS Healthcare GmbH)
- Standard ticket: CHF 230
- Members of Swiss Medtech, SVDI, ASDI or start-ups (established in the past three years): CHF 140