Day Two – 17 June 2025Tuesday, 17 June 2025 - CEST Time Zone

• With eyes mainly focusing on the EU MDR, which other wider regulations are there to be aware of which affect the medical device industry?

  • Sustainability

  • Data

  • Digital

• How can all stakeholders keep on top of this web of regulatory web?

• End to end case study of successful certification

• Technical file preparation and submission

• Notified body review

• Common questions, pain points and lessons

Please contact: Kristen Schott – kristen.schott@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

Description: Serious incidents related to medical devices must be reported to Swissmedic in Switzerland. The Medical Devices Vigilance (MDV) department is responsible for processing all incoming cases on time. TRICIA can carry out a risk assessment for reports from medical device manufacturers, which supports the MDV department in Swissmedic in assessing the risks of event reports. Internal figures show that the number of reported cases increases every year. With the introduction of the IvDV and the development of the GPx, a further increase in reported cases is also expected over the next few years. Automating the assessment would mean considerably less work for triage. Reports with little relevance can be processed independently, so that they can be better managed by employees therefore increasing organizational effectiveness. In addition, a more homogeneous assessment of cases is possible through the usage of TRICIA. TRICIA is a wonderful case within Swissmedic of what is possible when AI is integrated and thoroughly tested in a meaningful process within the organization.

• With a bigger focus on bringing innovation back to Europe, which innovation pathways are available?

  • Comparison of pathways from Europe, US, and beyond

• Industry case study: getting an innovative device to market

  • Lessons learned and alterations for other submissions

Your EUDAMED challenge as a manufacturer? Achieve a smooth, efficient, compliant and on-time registration of all your devices in 2025. Based on our multi-year expertise of accompanying manufacturers to become live in EUDAMED, we now unveil to you how you will be able to make it happen in a practical "do's and don't" session

• The surprising roadblocks of the "do it yourself" pathway
• Learnings coming from your peers - based on various company size/product portfolio/data quality and IT maturity
• How to trust both your data and your registration processes to be compliant

• With devices having to be registered in EUDAMED by Q3 2026, what is the current state of play?

  • Early experiences with using EUDAMED

  • Comparison to SWISSDAMED

  • Is there also a UK equivalent?

• Moving towards end of 2026 grace period – what do manufacturers need to do?

• Understanding the EHDS Act

• Developments

• Primary and secondary use

• The regulatory scope of the EHDS Act: MDR, IVDR, data legislation and AI Act

• Opportunities for innovation with the EHDS Act

• Key risks and mitigation

• Future proofing compliance and strategy in light of the EHDS

Following on from yesterday’s morning session, our experts take the time to answer your most asked questions, comments and concerns, as well as answer any leftover burning questions!