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

March Update: Post-Market Surveillance Insights, EU Evaluation, US Developments

This month’s edition focuses on post-market surveillance—one of the most misunderstood and inconsistently implemented areas of the MDR. 

[Download a Practical Guide to Device & IVD Post-Market Surveillance, Vigilance & Reporting]

We’ve brought together a variety of perspectives from manufacturers, notified bodies, legal experts, and regulators to make this topic more concrete. 

March marked the close of the European Commission’s targeted evaluation of the MDR and IVDR on March 21st. While we now wait for the formal summary, many of us submitted comments and hope to see clear, actionable responses. We’ll continue to follow the outcomes closely.

We are also watching developments in the United States, where the FDA continues to face internal challenges and public scrutiny. 

 For European stakeholders, this presents a moment to reaffirm the strength of our system and to lead by example—through transparency, collaboration, and consistency. At AKRA TEAM, we remain focused on practical support. 

In May, we’ll be publishing a special issue dedicated to literature review throughout the product lifecycle. 

 In June, we’ll host our in-person Quality Accelerator Program in Munich—designed as a fully interactive, learn-by-doing event for organizations that want to move beyond checklists and build systems that truly support innovation and compliance. Check out our website for more information and to register—seats are limited!

As always, we are here to support your work and welcome your feedback. Thank you for reading.

Warm regards,

Dr. Bassil Akra
CEO, AKRA TEAM GmbH