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

June Update: Medical Literature Review, EU AI Act, Medical Device Software (MDSW) Apps

This month, the spotlight of this issue is on Medical Literature Review, a critical component of compliance with EU MDR and IVDR, with profound applicability elsewhere.

[Download the Guide to Medical Literature Review]

In addition to this topic, the MDCG FAQ attempting to reconcile the EU AI Act (AIA) with EU MDR and IVDR, an MDCG document covering Medical Device Software apps on online platforms, and a Team NB position paper on the IVDR certification process were all of note recently.

What’s Happening with EU MDR and IVDR?

The EU AI Act (AIA) MDCG FAQ is of special interest. It includes the statement:

“The AIA does not define the concept of ‘user’ which is defined in the MDR/IVDR as any healthcare professional or lay person who uses a device.”

EU MDR & IVDR AIA FAQ Read more of the FAQ that MDCG released in June: “Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA).”

Key developments shaping the regulatory landscape also include:

Medical Device Software (MDSW) Apps Another June MDCG document, “Guidance on the safe making available of medical device software (MDSW) apps on online platforms,” outlines a cutting-edge area of interest.

IVDR Certification Process (including Pre-application, Application and Post Application phases An IVDR Certification position paper from Team NB offers a harmonised roadmap for pre-application, application, and post-certification activities to help streamline the conformity assessment process and reduce delays across notified bodies.

Not To Be Missed

Join top-tier industry experts in Munich this September 3–4 for the AKRA TEAM Quality Accelerator Program—a hands-on, two-day immersion designed to elevate your MedTech career with practical skills in CAPA, audit readiness, and Article 10a strategies, plus exclusive networking with notified bodies and regulatory leaders.

I hope to see you there.

Best regards,

Dr. Bassil Akra
CEO, AKRA TEAM GmbH