Over the five days, TÜV SÜD will present a strategy forum and a series of 16 different live webinars and hands-on sessions addressing the most challenging issues in the fields of Medical Device Regulation (MDR), In-Vitro Diagnostic Regulation (IVDR) and testing. TÜV SÜD’s global network, comprising experienced medical doctors, engineers, chemists and biologists, offers significant added value on the international medtech market. From experience, we know that medtech questions related to testing, certification and approval are best clarified directly in face-to-face meetings with experts in the field. Like last year, participants on all five days will again have the possibility to discuss their specific needs and objectives in virtual one-to-one meetings.

A new feature of Digital Dialogues Vol. 3 is the “MedTech Strategy Forum”. In this 30-minute kick-off event, the top management of Medical & Health Services at TÜV SÜD will talk about current trends and challenges, giving insights into TÜV SÜD’s vision for the medtech market and its position there. A live chat will offer participants the opportunity to ask questions.

Royth von Hahn, Senior Vice President Medical & Health Services: “The ultimate goal is always to improve patients’ quality of life. Progress represents the means to this end in the industry, with medical devices and IVD becoming increasingly important. We want to enable companies to get ahead and give them a lead. With this goal in mind, our Digital Dialogues Vol. 3 is held under the theme of “Get ahead with top-tier MedTech and IVD expertise”.

Digital Dialogues Vol. 3 is a further valuable event for all manufacturers, regulators and quality, approval, product development and IT professionals in the health and medtech industry who are seeking to drive innovation and lead the market.

On each of its of its five days, Digital Dialogues Vol. 3 will offer a range of online webinars or hands-on sessions. To allow participants maximum flexibility in their planning, the sessions will be held in the mornings from 8:30 am and repeated in the afternoons from 4:00 pm or 4:30 pm (CET) respectively. All webinars are held in English and are free of charge.

Programme details of the 5-day online event:

8 November: MDR
9:00 am and 4:00 pm: MedTech Strategy Forum – Dr Royth von Hahn, Dr Tobias Beck, Dr Sabina Hoekstra and Dr Andreas Stange
Following this kick-off event, the first day of the webinar series will again be dedicated to the current Medical Device Regulation (MDR), for which the transition period will end in May. The TÜV SÜD specialists will focus on selected specific requirements from the MDR’s extensive list of requirements, such as the requirements for aesthetic devices or combination products, and will provide updates on topics such as the UKCA marking and change management.
10:30 am and 5:30 pm ANNEX XVI: Emerging challenges for aesthetic manufacturers – Dr Melania Battistella / Dr Christiana Hofmann
11:30 am and 6:30 pm Change management under the MDR – Dr Michael Binder
12:30 pm and 7:30 pm UKCA mark update – Dr Monisha Philipps

9 November: Medical Device Testing (Part 1)
The second and third day of the webinar series will again focus on the increasingly important testing of medical devices. Topics such as market access to the USA/Canada, wireless/radio-specific approval, biocompatibility, accelerated ageing including transport simulation and sterile packaging, and MRI are on the programme.
9:30 am and 5:30 pm Market access to USA / Canada – Markus Herrmann, Hannes Adelsberger
10:30 am and 6:30 pm Wireless / radio-specific approval – Thomas Ring

10 November: Medical Device Testing (Part 2)
09:30 am and 5:30 pm Biocompatibility of medical devices – General strategies and common pitfalls – Dr Christoph D. Lindner
10:30 am and 6:30 pm Accelerated ageing incl. transport simulation and sterile packaging – Daria Meusburger, Roberto Singer
11:30 am and 7:30 pm MRI – safety of medical devices – Mahdi Abbasi

11 November: IVD Regulation & Testing
The Regulation on In-Vitro Diagnostic Medical Devices (IVDR) is on the agenda on day four of the webinar series. The sessions will cover discussions of the latest regulatory updates, the IVDR conformity assessment and experience gathered from IVDR technical documentation assessments
08:30 am and 4:30 pm IVDR conformity assessment – Dr Julien Senac
09:30 am and 5:30 pm Latest regulatory update | Part 1: General – Marta Carnielli, Dr Andreas Stange
10:30 am and 6:30 pm Latest regulatory update | Part 2: CDx, Class D, novel Class C – James Hewitt, Dr Eric Heilmann
11:30 am and 7:30 pm Lessons learnt on IVDR technical documentation assessments – Dr Ines Labugger

12 November: Hands-on sessions
The title says it all on day 5 of the Digital Dialogues Vol. 3: in a hands-on approach, the webinars will show participants how to use the checklists for the assessment of biological safety and the MDR and IVDR application forms.
09:00 am and 4:00 pm Checklists for biological safety assessments – Dr Andrea Hemm, Dr Trixi Hollweck, Frank Wirsching, Dr Stefanie Böllner
10:00 am and 5:00 pm MDR application forms – Annika Fröhlich, Christian Schröder
11:00 am and 6:00 pm IVDR application forms – Annika Fröhlich, Dr Pranav Patel

Further information and registration for the Digital Dialogues at: https://www.tuvsud.com/…