National MDR & IVDR Conference

Third country status to the EU: The experience of Switzerland & the UK

The conference will focus on the regulatory aspects of development and export (for manufacturers) and import and distribution (for traders). Invited guest speakers from Switzerland and the UK will address the main question: «(How) can we turn third country status into an advantage for our country?»

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

Registration

Programme

Morning

08.15 – 09.00 h

Doors and Registration

09.00 – 09.10 h

Welcome notes

Situation of the Swiss medtech industry and our ambitions for the future
Words of welcome by Dr Beat Vonlanthen, President Swiss Medtech
International collaboration and Free Trade Agreement UK-CH
Words of welcome by her Excellency Jane Owen, Ambassador to the Swiss Confederation and to Liechtenstein

09.10 – 10.45 h

Plenary programme: Politics and Regulation

The EU and MDR/IVDR: How do we get out of this mess?
presented by Dr Marc-Pierre Möll, CEO BVMed
The UK as third country: Where do we go from here?
presented by Phil Brown, Director Regulatory & Compliance, Association of British Health Tech Industries ABHI & Dr Neil Ebenezer, Medical Technology Specialist, Department of International Trade DIT, UK Government
Switzerland as third country: Where do we go from here?
presented by Dr Daniel Delfosse (Head of Regulation & Innovation, Swiss Medtech)
Round table – What can Germany, the UK and Switzerland learn from each other

10.45 – 11.15 h

Break

11.15 – 12.30 h

Breakout Sessions Morning

Session 1 – «For manufacturers»
Working with Notified Bodies under siege conditions
Session 2 – «For distributors»
The impact of the MedDO on import and availability of medical devices
Session 3 – «For IVD products»
Helicopter view on IVD regulation and lessons learnt from MDR

12.30 – 13.45 h

Lunch break

Afternoon

13.45 – 15.00 h

Breakout Sessions Afternoon

Session 4 – «For manufacturers»
How to bring new products on the market (national solutions)
Session 5 – «For distributors»
Possible supply shortages and solutions for the Swiss market
Session 6 – «For IVD products»
Focus on technical issues and performance evaluation

15.00 – 15.30 h

Break

15.30 – 17.00 h

Plenary programme: How to bring innovation to the Swiss & British patients

How does the UK support medical device innovations?
presented by Vishal Thakker, Head of UK Approved Body, BSI & Dr Neil Ebenezer, Medical Technology Specialist, Department of International Trade DIT, UK Government
How does Switzerland support medical device innovations?
presented by Stéphanie Lecaudé, Research Associate, Innosuisse & Sasha Hugentobler, National Contact Person Horizon Europe, Euresearch
Round table – Ways to make Switzerland & the UK more attractive for medtech companies
The next hot topic: How sustainable is the medtech industry? The example of Germany
presented by Dr Marc-Pierre Möll, CEO BVMed & Dr Sandra Zimmermann, Head of International Social Policy, WifOR Institute

17.00 h

End of event

Breakout Sessions

11.15 – 12.30 h «For manufacturers»

Session 1 – Working with Notified Bodies under siege conditions

Moderated by Enrico Perfler (1Med) & Deepa Rajagopalan (The Tao of Excellence)

Good practices in the interaction with Notified Bodies
presented by Maddalena Pinsi (BSI)
Notified body perspective on recertification of legacy devices – Experiences and common misconceptions
presented by Daniele Ricchi (TÜV Rheinland Italy)
Strategies and lessons learnt in the recertification of legacy devices
presented by Alessia Gatti & Lorenzo Bracchi (IBSA)
Q&A

11.15 – 12.30 h «For distributors»

Session 2 – The impact of the MedDO on import and availability of medical devices

Moderated by Simon Heusler (Axxos) & Jasminka Roth (CEO, The Tao of Excellence)

The MedDO journey as a Swiss importer – Case 1
presented by Patrick Fehrlin (Anandic Medical Systems)
The MedDO journey as a Swiss importer – Case 2
presented by Chantal Tellenbach (Neurolite)
The MedDO reality for hospitals
presented by Philippe Linder (Lucerne cantonal hospital LUKS)
Q&A

The presentations will be given in German, the slides projected in English.

11.15 – 12.30 h «For IVD products»

Session 3 – Helicopter view on IVD regulation and lessons learnt from MDR

Moderated by Holger Kloess (Senior Consultant, Qunique)

The multiple workload of IVDR
presented by Dr Alicja Ritz (ISS)
The future of IVDs – Curse or blessing for manufacturer?
presented by Doris Corpataux & Dr Damian Hertig (Ender Diagnostics)
IVDR after date of application – experience and status
presented by Dr Niclas Hitziger (Roche Diagnostics)
Q&A

13.45 – 15.00 h «For manufacturers»

Session 4 – How to bring new products on the market (national solutions)

Moderated by Frederike Brühschwein-Mandic (Confinis)

Experiences and lessons learnt – A snapshot of a journey into the MDR
presented by Chantal Benz (Geistlich Pharma)
How to place products onto the UK market – Experiences and lessons learnt
presented by Vishal Thakker (BSI)
How to place products onto the US market – Experiences and lessons learnt
presented by Dr Elena Lucano (Medidee)
Q&A

13.45 – 15.00 h «For distributors»

Session 5 – Possible supply shortages and solutions for the Swiss market

Moderated by Bernhard Bichsel (ISS)

Which products are/will be missing? Survey results
presented by Dr Daniel Delfosse (Swiss Medtech)
Experience with legal manufacturers from the perspective of a CH/EC-REP
presented by Angelina Hakim (CEO, Qunique)
Legal tools to get exceptions from the authorities
presented by Dr Andrea Schütz (Prager Dreifuss)
Q&A

13.45 – 15.00 h «For IVD products»

Session 6 – Focus on technical issues and performance evaluation

Moderated by Emilia Berg (Confinis)

Why the Intended Purpose is the key?
presented by Dr Silvia Anghel (Medidee)
Lessons learnt from first IVDR applications & performance evaluations – key learnings from a Notified Body’s point of view
presented by Dr Andreas F. Stange (TÜV SÜD)
EU Reference Laboratories, new IVDR concept: An insider’s view on the assessment process
presented by Dr Micha Nübling (Paul-Ehrlich-Institut)
Q&A