MDR Turning Point: What Changes with the Proposed Revision of the Medical Device Regulation?

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MDR Turning Point: What Changes with the Proposed Revision of the Medical Device Regulation?

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A few years after the entry into force of Regulation (EU) 2017/745 (MDR), the European Commission is taking action to make the system more sustainable. With the amendment proposal COM(2025)1023, Europe aims to cut red tape and boost the competitiveness of the medical sector—without compromising the strict safety standards of medical devices.In this podcast episode, we analyze the impact of this upcoming revision on manufacturers and industry operators.What we discuss in this episode:

Process Digitalization: How the transition to electronic documentation and digital workflows (linked to EUDAMED) will reduce the paperwork burden.
Flexibility for the PRRC: New opportunities for regulatory outsourcing—a breath of fresh air, especially for SMEs.
Streamlining vs. Safety: What is changing on the administrative front and why clinical evaluation and post-market surveillance requirements remain as strict and unchanged as ever.
Ongoing Challenges: The limited capacity of Notified Bodies and the structural bottlenecks that have yet to be resolved.

🎧 Tune in to find out how to guide your business through this regulatory evolution!📌 To delve deeper into the topic, read our full blog post: Revision of Regulation (EU) 2017/745 (MDR): Impact on Manufacturers

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