Join Our Webinars and Advance Your MedTech Market Access

How the first Joint Clinical Assessments are shaping the future of market access for medical devices and IVDs, and why the pharma playbook matters more than you think.

In this session, we’ll cover:

1. Contextualisation of the EU HTA for MedTech/IVD

2. JCA: One Framework, Two Tracks
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.

3. Who Gets Selected? The Device Selection Process
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.

4. Early Signals: Lessons from the Initial Expert Panel Consultations
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.

5. PICO Multiples: The New Challenge
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.

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

7. Recommended Actions

8. Q&A