Update - Welcome to the Second Issue of EU MDR & IVDR Insider

February Update: EU MDR Updates, Orphan Devices, and a Major Change for Clinical Trials

By Bassil Akra, PhD

Welcome to the second issue of EU MDR & IVDR Insider! This month, we focus on key developments shaping the regulatory landscape, including a major initiative that could transform how clinical trials are conducted in the EU: 

[Download the EU Orphan Device Clinical and Regulatory Playbook]

In This Issue:

• Orphan Devices & Regulatory Challenges – Expert insights on navigating CE marking for these critical yet often overlooked devices.
• EU MDR Public Consultation – With over 200+ submissions so far, many are just complaints. But if you want real change, constructive recommendations matter. The deadline for comments is March 21, 2025—now is the time to make your voice heard.
• New & Noteworthy: A Game-Changer for Clinical Trials – The European Commission has launched a pilot coordinated assessment program for clinical investigations and performance studies. This allows sponsors to submit a single application for trials spanning multiple Member States, reducing administrative burden and potentially cutting costs significantly for multi-country trials.
• Training & Professional Development – Announcing the launch of AKRA Team’s Accelerator Programs! Our first event, the Quality Accelerator Program, will take place June 24-25, 2025, in Munich—helping professionals move from compliance to strategic leadership.

Upcoming Webinars & Trainings

• March 4 – Clinical Evaluation Training
• March 20 – SSCPs Online Training
• March 27 – PMS, PMCF & PSUR Training

Stay informed, stay ahead, and as always—let’s keep pushing for regulatory clarity and smarter compliance.

Best,

AKRA TEAM

PS - Save the Date! The inaugural Quality Accelerator Program takes place June 24-25, 2025, in Munich. Become the go-to quality expert in your company. Email Alexia Lynch for more details.