EU MDR 2026: Clinical Evidence Strategy
Master the "EUDAMED Hard-Gate" and address critical clinical evaluation data deficiencies with former Notified Body reviewers.
Why Attend This Strategic Workshop?
Former Notified Body Reviewers
Direct insights from two former TÜV SÜD experts on how Notified Bodies evaluate clinical data under EU MDR.
Interactive Breakout Sessions
Engage in three round-table discussions focused on Article 61, PMCF strategies, and SOTA clinical claims.
Private One-to-One Consultations
Dedicated 20-minute private slots with our experts to discuss your specific clinical evaluation challenges.
Japanese HQ Specialized
Tailored for Tokyo-based manufacturers with professional translators provided for seamless technical support.
Leadership in Clinical Research Innovation
Acknowledged for our excellence in real-world evidence and data architecture. This achievement underscores our commitment to streamlining regulatory success for medical device manufacturers.
xShare Clinical Research Excellence
The Eclevar Standard in Tokyo
Date & Time
Friday, April 17, 2026
12:30 ~ 17:30
Venue Location
JETRO Innovation Garden
Ark Mori Bldg. 7F, Tokyo
Admission
Free of Charge
Strictly Limited to 30 Seats
Workshop Agenda
Introduction
MDR 2026: Navigating the EUDAMED Hard-Gate requirements and the latest enforcement updates.
Keynote Presentation
“Clinical Evidence - How to address the data deficiency in your clinical evaluation”
PMCF & Legacy Devices
Detailed analysis of Article 61 and Equivalence/WET. Determining your PMCF strategy.
SOTA & Claims
Defining measurable clinical claims and setting appropriate acceptance criteria for your CER.
Digital PMCF Data
Design of cost-effective PMCF surveys/studies using advanced EDC platforms.
One-to-One Consultations
20-minute private consultation with our experts to discuss your specific clinical questions.
Registration & Expert Consultations
Secure your seat for the Tokyo workshop and book a dedicated 1-to-1 session with our clinical & regulatory experts.
1 Workshop Registration
Limited to 30 seats. Register now to attend the presentations and round tables.
2 Book a 1-to-1 Session
Optional: Reserve a private 20-minute consultation slot during the event.