Medical Device Regulations in Motion: State of Play and What’s Next

This presentation examines the evolving landscape of Medical Device Regulations (MDR), providing practical insights for companies developing both hardware and software devices, with a particular focus on startups. We will start with a brief overview of the current regulatory environment and the role of Notified Bodies, highlighting how to identify the right body based on device classification and codes. The core of the session will guide attendees through the full certification process with BSI, from initial engagement and contract setup to document review, audits, and final CE marking. We will cover considerations specific to both hardware and software devices, emphasizing practical lessons and common pitfalls to avoid. A detailed look at BSI RS Medical Devices’ organizational structure will illustrate the range of device technologies they assess and the expertise supporting the certification process.

Finally, the presentation will explore regulatory updates and emerging trends, discussing potential future changes in MDR and how companies can prepare to stay compliant while innovating.
Attendees will leave with a clear roadmap for navigating certification, practical strategies for engaging with BSI, and a forward-looking understanding of how medical device regulations are evolving.

Speakers: Shruti Gangwal & Sreenath Sukumaran, BSI