Is Your Cardiology Device
Ready for Europe?
A Clinical, Regulatory & Operational Readiness Self-Assessment for sponsors planning a structural heart or coronary clinical trial in Europe.
Important: This checklist provides a non-binding, informational readiness assessment only. It does not constitute regulatory advice or a conformity assessment under applicable EU regulations.
Why Use This Readiness Checklist?
Entering Europe for a structural heart or coronary clinical trial is a significant milestone. The difference between a smooth study launch and a delayed, resource-intensive one often comes down to preparation.
Clinical Readiness
Evaluate feasibility, site selection, and imaging or endpoint preparedness for structural heart and coronary studies.
Regulatory Readiness
Assess MDR alignment, country-specific pathways, ethics timelines, and indemnification considerations.
Operational Readiness
Review contracting, monitoring strategy, device logistics, long-term follow-up, and local expertise.
This checklist is designed to help sponsors assess whether they are truly ready to initiate a structural heart or coronary trial in Europe. It is not simply a regulatory exercise. It is an operational, strategic, and clinical readiness assessment based on the reality of the European environment.
If several of these areas remain unclear or unresolved, it is usually a sign that additional planning and experienced regional support may be needed before moving forward.
How to Use This Checklist
Read the criteria listed under each of the 7 areas, then select the answer that best reflects your current readiness. At the end, your total score identifies your EU readiness tier.
Maximum score: 21 points across 7 questions.
3 points — Fully in place
Strong readiness. This area is addressed, documented, and operationally ready.
2 points — Partially in place
Minor gaps remain. Core elements are in place but some details need to be resolved.
1 point — Early stage
Significant gaps exist. This area has been started but is not yet operationally ready.
0 points — Not yet addressed
This area has not yet been formally assessed or planned.
Ready to Check Your Readiness?
Complete the 5-minute checklist to receive your readiness tier and a per-area breakdown across regulatory, clinical, and operational dimensions.