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.
- Situation of the Swiss medtech industry and our ambitions for the future
Words of welcome by 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
- 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
- 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 Switzerland and UK learn from each other
- How does the UK support medical device innovations?
presented by Vishal Thakker, Head of UK Approved Body, BSI & Neil Ebenezer (Department of International Trade, UK Government)
- How does Switzerland support medical device innovations?
Speaker not yet confirmed
- 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
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)
- Strategies and lessons learnt in the recertification of legacy devices
Speaker not yet confirmed
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)
11.15 – 12.30 h «For IVD products»
Session 3 – Helicopter view on IVD regulation and lessons learnt from MDR
13.45 – 15.00 h «For manufacturers»
Session 4 – How to bring new products on the market (national solutions)
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 Andrea Schütz (Prager Dreifuss)
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)
Silvia Anghel developed a strong scientific expertise of research in highly competitive and international laboratories in Canada and Switzerland, performing research in the fields of oncology, metabolism related disorders, and gastroenterology. She also acquired an industrial experience by working at different positions in the healthcare industry in the field of In Vitro Diagnostics (IVD). She is currently Associate Director and Head of IVD Group.
Chantal Benz joined Geistlich Pharma AG in 2021 as RA Manager and is mainly responsible for EU/EFTA and MDR transition of product documentation. After studying chemistry, she worked in the IVD industry and then moved into the field of joint replacement and later dental implantology. In addition to her in-depth MDR expertise in RA/QM, she is a certified quality management consultant.
Emilia Berg, MSc Biomedical Engineering, has experienced the IVD field from various perspectives, starting her career in university research, and working at the Finnish competent authority for medical devices. Industry roles in Switzerland made her an expert in design quality controls for IVD product development. As senior consultant at confinis, Emilia currently supports various IVD actors both within Switzerland and internationally in meeting quality and regulatory requirements.
Bernhard Bichsel works as Strategic Business Developer and Senior Consultant at ISS AG in Biel. He is the former Head of the Medical Devices Division at Swissmedic and originally graduated as an elec-trical engineer, followed by an Executive MBA in general management at the University of St. Gallen. He has a broad background on Medical Devices and has sounding managing and project experience.
Phil has been ABHI’s Director of Regulation and Compliance since 2016. In addition to his trade association responsibilities, Phil is Chair of BSI’s TC/210 Standards Working Group and a Fellow of TOPRA. After graduating with a degree in chemistry in 1984, Phil began his career at Smith and Nephew. During his career he has been involved with new technologies and has worked with national authorities, the European Commission, trade associations and standards bodies.
Senior consultant at confinis enabling clients to implement and pass the MDR requirements as well as supporting them to gain access to the US market. Before joining confinis ag as a senior consultant, Frederike worked eleven years in the field of mechanical ventilation heading the Q&RA department and two years in the field of radiology devices. She obtained her biolmedical engineering degree in Hamburg and her eMBA (FH) in St.Gallen.
Current position as Head of Global Regulatory Affairs at ender diagnostics ag with a 9-year experience in IVD industry. Regulatory representative in design process, establishing the complete technical documentation. Product registration worldwide (e.g., Australia, Canada, Russia, Brazil). 4 years lead of the laboratory in charge of product transfer from R&D to production.
Dr Daniel Delfosse has been Head of Regulation & Innovation and a member of the Executive Board at the industry association Swiss Medtech since 2020. His mantra is «innovation despite regulation» and he pursues the goal of keeping Switzerland as attractive as possible as a location for the medtech industry. Before that, he was Head of Innovation and a member of the Executive Board at Mathys Ltd Bettlach for almost 20 years.
Patrick is responsible for Operations (Sales Administration, Quality Management, Service Department, Logistics and Finance) within Anandic Medical Systems AG. He has over 20 years of experience in the Medtech industry and has been with Anandic for over 15 years. He has an economic background and holds an MBA.
Angelina Hakim is the owner and CEO of QUNIQUE Group. She holds a MSc in Biomedical Engineering, certified MDSAP and ISO 13485:2016 lead auditor and has more than 15 years of experience in the medical device industry. Thanks to her detailed knowledge about MDR requirements, she is able to combine her past experience with the new requirements to train and support customers around the world.
Product owner at ender diagnostics ag with the lead in product development of in-vitro diagnostic devices, as well as design related project activities and reviews. With a PhD in biomedical sciences around 6 years of background in research and development of in-vitro diagnostic screening methods as well as experience in (pre)clinical research.
Holger Kloess is Senior Consultant at QUNIQUE Group. He holds a Master’s degree in Biology, certified MDSAP and ISO 13485:2016 lead auditor and has more than 10 years of experience in the medical device industry and product development. Thanks to his detailed knowledge about MDR requirements, he can combine his past experience with the new requirements to train and support customers around the world.
Philippe holds a Master of Arts in Economics, Information and Technology Management from the University of St. Gallen. As Head of Purchasing and Logistics at the lucerne cantonal hospital he is responsible for the whole Supply Chain Medical Consumables, CAPEX and Textile Supply. He has many years of experience in the manufacturing industry of consumer goods.
Dr Marc-Pierre Möll has been Managing Director of the German Medical Technology Association (BVMed) in Berlin, Managing Director of the BVMed Academy and member of the BVMed Board since April 2019. The political scientist with a doctorate has many years of experience in health policy. From 2008 to 2019, he headed the «Government and Parliament» department at the Association of Private Health Insurers (PKV) in Berlin. Before that, he had headed two parliamentary offices.
Micha Nübling joined in 1990 the Virology Division of the Paul-Ehrlich-Institut assessing high-risk in vitro diagnostics. In 2002 he qualified as lecturer for medical virology at Frankfurt university. From 2015 to 2018 he joined WHO headquarters in Geneva as head of the «Blood and related Biologicals» section. Since 2018 he coordinates internal and international regulatory issues as head of division «Major Policy Issues».
Deepa Rajagopalan dons the hat of Quality Implementation manager at the Tao of Excellence. She has rich experience in the entire spectrum of quality systems and believes in continuous learning. The cross-industry view she brings to the table is a function of time in automotive, aerospace and med-tech space. A chemical and electrochemical engineering degree kick started her professional career.
Senior Regulatory Affairs Manager and IVD Expert at ISS AG. Alicja received a PhD in biochemistry from the University of Basel. She began working as a regulatory affairs manager at BÜHLMANN Laboratories AG, later taking over the responsibility for the regulatory affairs department. Alicja has experience in international IVD registrations, performance evaluation and vigilance system support and has seen through a successful IVDR transition.
Jasminka Roth is the founder and CEO of ‘The Tao of Excellence’, a service provider for strategic, tactical and operational support in quality, regulatory and clinical affairs. Her passion lies in developing an integrative approach to business challenges. Her experience spans the healthcare, pharmaceutical and medical device industries. She holds a MSc and BSc in biochemistry and biotechnology from ETH Zürich.
Dr Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD Product Service. He serves as the global responsible for the In-vitro Diagnostic Devices business line. Based in Japan, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia and West Europe. Before taking the current position in March 2017, he was President & CEO of TÜV SÜD in Japan.
Vishal is currently Head of UK Approved Body for Medical Devices being responsible for the regulatory oversight of the Approved Body and wider BSI strategy, to meet the various legislative and designation requirements. He has held various roles within BSI over the past 6 years as a Regulatory Lead and Technical Team Manager. He holds a MEng in Medical Engineering from QMUL and has over 10 years' experience within the medical devices industry.
Chantal has worked in the medical industry since 2015. From 2017 to 2020 she worked for Neurolite taking care of customer and administration services. During a year at Klasa Holding AG, she gained experience in setting up a QM system. Since October 2021 she is back at Neurolite and responsible for building a QM system according to ISO 9001 with the support of the company Axxos.
The following elements are included in the ticket price:
- Conference ticket incl. refreshments
- Access to list of participants and presentation documents
- Certificate of attendance
CHF 430 – Standard ticket
CHF 290 – Reduced ticket
The following participants are granted a 33% discount on the standard rate:
- Swiss Medtech members
- SVDI/ASID members
- SwAPP members
- Swiss Dental Industry Association members
- Representatives of public authorities / politics
The event will be held at BERNEXPO Congress 1.3.
Information on how to get there and access to parking can be found here.