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?

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• End to end case study of successful certification

• Technical file preparation and submission

• Notified body review

• Common questions, pain points and lessons

• 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

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• 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?

Please contact: Neha Singh– neha.singh@informa.com If you are interested in participating as a speaker, panelist, moderator or hosting a webinar

• 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!