CE Mark Won't Pay Your Bills. Reimbursement Will.
Why CE marking alone is not a market access strategy, and how to build reimbursement into your device plan from day one
🕐 5 PM CET / 11 AM ET / 8 AM PT
About this webinar
For many medical device companies, the CE mark feels like the finish line. In reality, it is only the starting point. Without a reimbursement strategy, even a fully compliant device can fail to reach patients, because hospitals and healthcare systems will not pay for it.
In this 60-minute webinar, QbD Group looks beyond regulatory approval and into the economic reality of market access. Anne-Sophie Grell and Marco Kalms explain how reimbursement pathways differ across European markets, what evidence payers and health technology assessment bodies expect, and when reimbursement planning should start in your development timeline.
The session connects regulatory strategy with market access thinking, showing how early decisions on clinical evidence, intended use and target markets directly influence your reimbursement options later.
What You'll Learn
- Why CE marking alone does not guarantee market uptake or revenue
- What evidence payers and HTA bodies expect beyond the technical documentation
- When to start reimbursement and market access planning in your device development
- How regulatory and reimbursement strategies can reinforce each other instead of competing for budget
- How reimbursement systems differ across key European markets
Speakers
Anne-Sophie Grell
Regulatory Affairs Expert · QbD Group
Doctor in Physic as background. She began her career as an MRI researcher at a cancer hospital, then earned a Master's in Medical Physics and oversaw quality control across imaging and radiotherapy. In 2010, she moved to the private sector as Quality and Regulatory Affairs Manager at IBA. Since then, she has held various regulatory and QA roles at IBA and Philips, and for nearly five years at QbD Group. Along the way, she has worked with competent authorities and notified bodies worldwide to discuss registration strategies. Today, she helps clients define the right regulatory strategy to bring their medical devices to market in Europe, the US, and Asia.
Marco Kalms
Founder & CEO, KALMS
Marco has more than 30 years of leadership experience in healthcare, covering commercial strategy, market access and reimbursement. At American Medical Systems (now part of Boston Scientific), he rose to Managing Director Europe and led market access and commercialization of innovative medical technologies across EMEA. In 2012 he founded the Kalms Group, which supports international medtech, diagnostics and health IT companies with reimbursement, market access and operational set-up in Europe.
Who Should Attend
- CEOs, CFOs, VP Regulatory, VP Commercial and Heads of Market Access at US medtech companies (medical devices, IVD, digital health) planning European entry
- US medtech companies with CE marking recently obtained but limited EU revenue so far
- European medtech companies with regulatory clearance but uncertain reimbursement