National Regulatory Conference

Everything you need to know about present and future regulations

The National Regulatory Conference will shed a light on all regulatory aspects that will affect the medtech industry today and in the near future. Aside from the ongoing matters around MDR/IVDR and the Swiss MdeDO/IvDO, it will also deal with the use of health data and the reporting of sustainability topics.

A plenary session will show in a concise overview what everybody needs to know about medical device regulation, health data, sustainability and corporate governance. Following that, plenty of time is reserved for breakout sessions where the individual topics will be addressed in depth.

Secure your ticket now, as the attendance is limited to 500 participants. The event language is English.

National Regulatory Conference
18 October 2023

BERNEXPO Congress 1.3
Mingerstrasse 6, 3014 Bern


08.30 - 09.15 h
Doors and Registration
09.15 - 09.25 h
Welcome note: Situation of the Swiss medtech industry and our ambitions for the future
Dr Beat Vonlanthen, President Swiss Medtech
09.25 - 10.45 h
Plenary programme: Politics and Regulation
Moderated by Dr Daniel Delfosse, Head of Regulation & Innovation Swiss Medtech
  • Handling of health data: what everyone needs to know
    Dominik Geller, Hygiaso
  • Non-financial reporting and supply chain management: what everyone needs to know
    Simon Heller, Deloitte
  • Status of acceptance of FDA approved products for Switzerland
    Sandra Rickenbacher-Läuchli, Head of Public Affairs & Legal Counsel Swiss Medtech
  • Round table «Third country to the EU: How the UK is shaping its medical device regulation»
    Phil Brown, Director Regulatory & Compliance, Association of British Health Tech Industries ABHI with Dr Daniel Delfosse
10.45 - 11.15 h
11.15 - 12.30 h
Breakout Sessions Morning
  • Session 1 – MDR/IVDR
    «Pain points for Swiss economic operators»
  • Session 2 – Health Data
    «The European framework for handling of health data»
  • Session 3 – Sustainability
    «The European & Swiss framework for sustainability and reporting of ESG»
12.30 - 13.45 h
Lunch break



13.45 - 15.00 h
Breakout Sessions Afternoon
  • Session 4 – MDR/IVDR
    «How to bring innovations on the market in Europe»
  • Session 5 – Health Data
    «Electronic health data in Switzerland»
  • Session 6 – Sustainability
    «The carbon footprint for the Swiss medtech industry»
15.00 - 15.30 h
15.30 - 16.45 h
Plenary programme: Success stories
  • Genom meets iPhone – Health data and data democracy
    Prof. Ernst Hafen (Swiss Health Data Space)
  • Smart segregation of Medical Device Software (MDSW)
    Christoph Anderegg (ISS AG, Integrated Scientific Services)
  • Sustainability in a hospital – Requirements for medtech companies
    Sarah Näther (PwC AG)
  • The journey of thousand miles begins with a single step
    Teresa Pablos (Johnson & Johnson MedTech)
  • Funding opportunities in Europe? Yes, more than you think!
    Sasha Hugentobler (Euresearch)
  • Outlook & Farewell
16.45 h
End of event

Breakout Sessions


Breakout Session 1

11.15 – 12.30

Pain points for Swiss economic operators

moderated by Markus Wipf (Axxos)


  • How to prepare for Swissmedic inspections of manufacturers, CH-REPs and importers
    Dr Sebastian Fuchs (Swissmedic)
  • Pitfalls for importers and distributors
    Angelina Hakim (Qunique)
  • 5000 articles from 200 manufacturers – Case report of the MedDO implementation at a large Swiss distributor
    Janik Weigele (Gribi Belp)

Breakout Session 2
Health Data

11.15 – 12.30 h

The European health data space – Impact on Switzerland

moderated by Jasminka Roth (The Tao of Excellence)


  • EU data laws affecting the MedTech industry and implementation in Switzerland
    Eva von Mühlenen (Sidley)
  • MedTech Europe Position on EHDS (European Health Data Space)
    Verena Thaler (MedTech Europe)
  • Preparing the Health Data Foundation in Switzerland
    Rajesh Nair (Post CH Kommunikation AG)

Breakout Session 3

11.15 – 12.30 h

The European & Swiss framework for sustainability and reporting of ESG

moderated by Dr Holger Hoffmann-Riem (Go for Impact)


  • The impact of the EU laws on medtech companies (The green deal)
    Jesus Rueda Rodriguez (MedTech Europe)
  • What is requested from you? How to deal with the EU laws – no overkill
    Simon Heller (Deloitte)
  • Crossroads of EU and Swiss reporting initiatives for Swiss based companies
    Johann Weicht (ERM)


Breakout Session 4

13.45 – 15.00 h

How to bring innovations on the market in Europe

moderated by Frederike Brühschwein-Mandic (Confinis), Michael Maier (Medidee)


  • First experience with (technical documentation of) AI under the MDR: what is needed
    Prof Dr Stephen Gilbert (Else Kröner Fresenius Center for Digital Health)
  • Handling of conformity assessment requests for Medical Device innovations by TÜV Süd
    Alberto Mangone (TÜV Süd Italy)
  • How to get clinical data for innovative products
    Andrea Biasiucci (confinis)

Breakout Session 5
Health Data

13.45 – 15.00 h

Electronic health data in Switzerland

moderated by Bernhard Bichsel (ISS AG)


  • Navigating the future of healthcare: Exploring DigiSanté's role in healthcare transformation
    Matthias Becher (BAG, Federal Office of Public Health)
  • Eye to eye with AI: Opportunities and pitfalls
    Prof Raphael Sznitman (CAIM, University of Bern)
  • Health data's edge – Insights in a data-rich era
    Jasminka Roth (The Tao of Excellence)

Breakout Session 6

13.45 – 15.00 h

The carbon footprint of the Swiss medtech industry

moderated by Barbara Mettler (Swiss Medtech)


  • Practical implications of the new Swiss requirements on climate-related disclosures
    Jonathan Schwieger (First Climate)
  • Ambitious journey to net-zero: challenges and promising approaches of a manufacturing company
    Sabine Huber (Ypsomed)
  • Tackling carbon accounting and the roadmap to Net-Zero
    Raïna Rasper (Cendres+Métaux)


Hafen Foto


The following elements are included in the ticket price:

  • Conference ticket incl. refreshments
  • Access to list of participants and presentation documents
  • Certificate of attendance


The event will be held at BERNEXPO Congress 1.3. 
Information on how to get there and access to parking can be found here.

Area under construction

The expo area is currently undergoing major cunstruction. Therefore, the access route has changed slightly, see detailed plan below.

We recommend to exit Tram no. 9 at the stop "Wankdorf Center" and following the signs from there for easiest access to Congress 1.3.

The registration platform is closed. For last minute participation please write an e-mail to


Dr. Daniel Delfosse

Vice Director

Head of Regulation & Innovation

+41 31 330 97 74


Bettina Knellwolf

Project Manager


+41 31 330 97 77