Join Our Webinars and Advance Your MedTech Market Access

JCA: One Framework, Two Tracks — Mattias Kyhlstedt
The JCA procedure for medtech/IVD vs. pharma: same regulation, different mechanics. Key differences in triggering, scoping, dossier templates, and timelines. What the submission template demands from device and IVD manufacturers, and where it mirrors (and diverges from) the pharma template.

Who Gets Selected? The Device Selection Process — Mattias Kyhlstedt
How the HTACG recommends devices and IVDs for JCA, how the Commission decides, and what the selection criteria mean in practice. What "innovative" and "potential cross-border impact" look like through the eyes of the regulators.

Early Signals: Lessons from the Initial Expert Panel Consultations (10 min) — Mattias Kyhlstedt
What the first expert panel opinions on medtech and IVD clinical evaluations reveal about HTA expectations. Where expert panels are pushing back, and what this means for clinical development and evidence generation strategies.

The PICO: Your Evidence Blueprint — Mattias Kyhlstedt
How the PICO scope is set, why it matters more than any other single element, and how to engage with it strategically. The comparator challenge for devices: active surveillance, sham procedures, and standard of care. Lessons from pharma on managing PICO negotiations.

The Integrated Clinical Strategy: From JCA to Local Adaptation — Mattias Kyhlstedt
How to design a clinical evidence programme that satisfies JCA requirements while preparing for national-level HTA adaptation (Germany's BfArM, France's HAS, etc.). Aligning MDR/IVDR clinical evaluation with HTA evidence needs. Building one strategy, not two.

Augmenting Your Evidence: Indirect Comparisons and Real-World Evidence — Mattias Kyhlstedt
When your evidence base does not include head-to-head RCTs against the PICO comparator, what are the options? The role of indirect treatment comparisons (ITC/NMA), real-world data from device registries, and how the JCA framework accommodates (and scrutinises) these approaches.

From the Front Line: Pharma Lessons from the First JCAs (10 min) — Dr Stephanie Stengel, Dr Katja Ritz-Jansen (Ecker & Ecker)
Ecker & Ecker has supported three of the first JCAs in oncology. What worked, what didn't, and what every medtech company can learn from the pharma experience: dossier preparation, interaction with the assessor/co-assessor, timeline management, and stakeholder engagement.

Panel Q&A (15 min) — All speakers