A digital health tool’s qualification and classification status determine market access.
Understanding whether a product is considered a medical device or falls under another regulatory category influences:
- Applicable regulatory pathways and timelines
- Clinical, economic and organisational evidence requirements
- Reimbursement eligibility and payer expectations
This is challenging for software-based medical devices because regulatory frameworks often lag behind technological advancements, leading to classification ambiguity. Many digital health solutions blur the lines between wellness products and regulated medical devices. Different jurisdictions have varying classification criteria, making global market access complex. Additionally, the dynamic nature of software adds another layer of difficulty in maintaining compliance and user safety.
Misclassification can lead to delays, increased costs, or even market rejection.
Master qualification and classification frameworks for digital health tools across major markets.
This interactive workshop provides digital health innovators with a comprehensive understanding of product qualification and classification across major markets.
The session will cover both rules-based classification (e.g., EU MDR/IVDR frameworks) and predicate-based classification (e.g., FDA risk-based approach for Software as a Medical Device). Participants will explore the critical role of classification in determining regulatory pathways, compliance obligations, and market access strategies. We will explore how different regulators assess risk, intended use, and evolving software functionalities.
Efficient Learning
Video tutorials with real-world examples guide you through every detail.
Industry Expert Led
Developed and taught by medical device experts and founders.Actionable Outcomes
Walk away with a practical blueprint to guide your medical device development journey.Through this framework, participants will gain practical tools to approach corporate partnerships with confidence, ensuring they contribute meaningfully to business success.
Workshop Details
A tailored 1:1 workshop is a customised session designed specifically for your company, focusing on your digital health product’s unique regulatory challenges and market access strategy. This format allows for in-depth discussions, hands-on classification exercises, and expert guidance tailored to your business needs. A customised 4h session focused on your product’s regulatory challenges, market access strategy, and hands-on classification exercises. Welcome Introduction | 15 min Session 1: Software as a Medical Device (SaMD) Qualification | 45 min Session 2: Rules-Based Classification | 60 min Break | 25 min Session 3: Predicate-Based Classification | 45 min Session 4: Navigating borderline cases | 35 min Closing Remarks & Key Takeaways | 15 min Note: Timings are approximate. The workshops are tailored to the participants’ needs. It can be completed in a single morning or afternoon session of ~4h. Ideal for startups that want a highly customised, hands-on workshop with privacy and direct guidance to accelerate their market access strategy. With a PhD in biophysics and bioengineering (Oncology) and two decades of hands-on industry experience, I’ve spent my career leading and shaping R&D programmes across the medical device sector. I’ve founded and supported several spin-out and startup companies, translating early scientific concepts into manufacturable and regulator-ready technologies. Beyond startups, I’ve worked and consulted for multiple multinational medical device and pharmaceutical companies, helping R&D and innovation teams design robust development pathways and build portfolios that can withstand real-world regulatory, technical, and commercial scrutiny. Participants should be in the early stages of developing a new medical device product and have drafted one or more intended purpose statements. These will form the basis of the workshop. Particpants could come from: It may be helpful to complete the free MedDev Central mini-course: MedDev 101: Is it a medical device? in advance. Price: EUR 1500 Includes: Unlimited access to course materials used during the workshop. 12 months of access to supporting course materials, downloadable qualification and classification toolkits and certificate of completion. Need a custom package? We offer tailored solutions for large teams, academic institutions, and accelerators. Contact us to discuss enterprise licensing or co-branded delivery.Workshop Programme
Format
Instructor
CEO and Founder, MedDev CentralWho is it for?
Pricing
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