MDR & IVDR national conference
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Switzerland as a third country
On 26 May 2021, the Swiss medical technology industry was downgraded to «third country» status. How is the sector doing today? What are the short- and long-term consequences of the EU's political turmoil for the (to-date very successful) Swiss medtech industry? What are the most pressing problems? And how can they be solved?
Swiss Medtech has invited industry representatives to meet in Bern on 19 October to discuss these questions. Take this opportunity to discuss them in person. To kick things off, we will be asking Thomas Cottier, Professor Emeritus of European and International Business Law, to explain the possible legal options. In addition, you can expect a varied programme including two plenary sessions, various panel discussions, networking opportunities, and six breakout sessions focusing on each of the crucial issues.
MDR & IVDR Conference
19 October 2021
BERNEXPO
Mingerstrasse 6, 3014 Bern
Website
Program
08.30 – 09.00 h: Registration & Coffee
09.00 – 09.45 h: Plenary Session 1 – Political background and regulatory implications
- Welcome by the organiser
→ Dr. Beat Vonlanthen and Peter Biedermann, Swiss Medtech - Switzerland as a third country: how did it come to this? Where do we stand now?
→ Dr. Daniel Delfosse, Swiss Medtech - Is the MRA CH-EU coming after all?
→ Christophe Perritaz, SECO - Necessary measures without MRA and status of the revision of IvDV & MepV
→ Alessandro Pellegrini, BAG - EU Commission «Notice to Stakeholders» – Politics before law
→ Andreas Balsiger Betts, Sidley Austin LLP
09.45 h – 10.30 h: The talk
- Dr Daniel Delfosse in conversation with Prof. Thomas Cottier
«Swiss Medtech as a Third Country - What are the Legal Perspectives?»
10.30 – 11.00 h: Break
11.00 – 12.30 h: Breakout Session 1
Congress 1: MDR Topic 1 – Manufacturer/Exportation with focus on export to the EU
- Legal basis, possible constellations, mandate agreements and legal consequences
→ Michael Maier, Medidee Services SA - Insurance solution, company and product registration, interfaces and processes
→ Markus Wipf, Axxos GmbH - Q&A
Congress 2: MDR Topic 2 – Distributer/Importation with focus on import into Switzerland
- Roles and requirements for importers and distributors
→ Angelina Hakim, QUINIQUE - Implement CH-REP requirements correctly
→ Jasminka Roth, The Tao of Excellence - Contract design
→ Dr. Christoph Willi, Streichenberg & Partner - Q&A
Congress 4: IVDR Topic 3 (in English) – Manufacturer with focus on lessons learnt to consider in your IVDR transition
- Experience from a journey to MDR & IVDR compliance
→ Christoph Schär, QUNIQUE - Mind the gap: How to navigate the IVDD-IVDR transition
→ Carsten Krafcsik, Tecan Trading AG - The multiple dimensions of IVDR
→ Niclas Hitziger, Roche Diagnostics International AG - Q&A
12.30 – 13.30 h: Lunch
13.30 – 15.00 h: Breakout Session 2
Congress 1: MDR Topic 4 – Manufacturer/Exportation with focus on important aspects of clinical evaluation under MDR
- Pre-clinical data
→ Dr. Karin Ackema, ISS AG - Requirements for clinical trials
→ Dr. Isabel Scuntaro, Swissmedic - PMCF as part of Post Market Surveillance
→ Deborah Morgenthaler, ISS AG - Q&A
Congress 2: MDR Topic 5 – Distributer/Importation with focus on new challenges and hurdles
- MDR requires retailers and health facilities to
→ Peter Studer, confinis ag - MDR and Switzerland's third-country status – challenges in the retail trade
→ Azra Dizdarevic, Migros-Genossenschafts-Bund - Implementation of the MedDO/IVDR in the Insel Gruppe
→ Christian Offergeld, Insel Gruppe AG - Q&A
Congress 4: IVDR Topic 6 (in English) – Manufacturer with focus on technical documentation
- Review of the technical documentation requirements and current gaps
→ Dr. Silvia Anghel, Medidee Services SA - How should we tackle the performance evaluation and clinical evidence?
→ Dr. Heike Möhlig-Zuttermeister, BSI Group Deutschland GmbH - How can we take advantage of Post Market Surveillance data to upgrade the clinical evidence of legacy IVD devices?
→ Robyn Meurant, ACT-IVD - Q&A
15.00 – 15.30 h: Break
15.30 – 17.00 h: Plenary Session 2: Quo vadis? The Swiss way into the future
- Change of a Notified Body under high time pressure
→ Oscar Banz, Thommen Medical AG - Successful transfer of technical documentation from MDD to MDR
→ Kristin Fuchs, Ypsomed AG - Dealing with the uncertainty of MDR implementation
→ Martin Koller, Ulrich AG - Successful MDR transition: Industry example
→ Shokoufeh Khodabandeh, Institut Straumann AG - Panel discussion
- Survey and farewell
