INITIATING PRE-MARKET CLINICAL INVESTIGATIONS IN THE EU: WHAT YOU NEED TO KNOW

This well-attended on-line Masterclass was a practical deep dive into how to successfully plan and launch pre-market clinical investigations in the EU under the MDR. Attendees discovered how to navigate country differences, identify the right investigators and sites, and streamline approvals for faster study starts. The speakers shared proven strategies to avoid costly delays and ensure smooth progress from site selection to first patient in — and beyond.

Daniela Karrer (VP Operations and Clinical Affairs) and Matteo Mosso (Director, Clinical Affairs) from Donawa Lifescience shared their experiences in this Event by MedTech Leading Voice that took place on Wednesday 29 October 2025, revealing what 20+ years of managing EU studies has taught them; that success comes from sowing wisely at the start — so as to reap strong, on-time, and on-budget results later on.

Attendees learned:
• To evaluate and select EU Investigators and clinical sites strategically
• To effectively navigate through Competent Authority and Ethics Committee submissions, MDR requirements and country variations
• To avoid early-stage mistakes that jeopardize enrollment success.

Specific topics covered included:

 Engaging investigators and study teams effectively
 Pilot vs. pivotal study investigator requirements
 Evaluating and selecting clinical sites for strong enrollment.
 Submissions to Competent Authorities and Ethics Committees
 Early best practices that help prevent later challenges
 Study budget considerations