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

January Update: EU MDR and IVDR Developments and the Strategic Implications of Article 10a

By Bassil Akra, PhD

This month, the spotlight is on Article 10a, a critical regulatory requirement coming into effect on January 10th, 2025. At its core, Article 10a aims to safeguard the European healthcare system by ensuring proactive communication about device supply interruptions or discontinuations.  

[Download the Complete Guide to Article 10a Compliance and Mastery]

But beyond compliance, there is a significant strategic opportunity for manufacturers to demonstrate leadership in regulatory readiness and patient safety.

As Erik Vollebregt said during the webinar:

"This provision isn’t just about compliance—it’s an opportunity for manufacturers to showcase their commitment to healthcare system continuity, gaining trust and positioning themselves competitively."

What’s Happening with EU MDR and IVDR?

December 2024 brought some key developments shaping the regulatory landscape:

European Commission

Launch of Public Consultation and Call for Evidence for EU Medical Devices Evaluation (December 12, 2024):

The European Commission initiated a public consultation to gather feedback on the performance of the medical device regulations and seek input from stakeholders to inform future policy decisions.

MDCG

Manufacturer Information Form on Interruption or Discontinuation of Supply (MDCG 2024-16) (December 6, 2024):

The MDCG released guidance to assist manufacturers in notifying authorities about interruptions or discontinuations in the supply of certain medical devices and in vitro diagnostic devices, aiming to ensure transparency and maintain device availability. 

MedTech Europe

Post-EPSCO Statement on MDR/IVDR Reforms (December 4, 2024):

Following the Health Council (EPSCO) meeting on December 3, 2024, MedTech Europe emphasized the urgent need for reforms in the MDR and IVDR frameworks. 

Looking Ahead

The European Parliament is expected to debate MDR revisions in the coming months, focusing on balancing innovation and patient safety. These discussions could reshape the regulatory landscape and provide much-needed relief for manufacturers navigating CE marking challenges.

We hope you find this issue to be useful.

Best regards,

Bassil Akra, PhD

PS Don’t miss the EU Orphan Devices webinar on January 21st