Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan

Device Advice by RQM+

This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by ⁠⁠completing the form on this page⁠⁠. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the ⁠⁠⁠Knowledge Center⁠⁠⁠ or ⁠⁠⁠Events⁠⁠⁠ pages at RQMplus.com.

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Summary

In this conversation, panelists discuss the crucial role of Notified Bodies in the EU regulatory environment for IVDs and medical devices. They highlight the challenges faced by manufacturers due to changing regulations and the consultative nature of Notified Bodies, emphasizing the differences between the decentralized EU regulatory structure and the US system.

The panelists provide updates on the extended transition timelines for IVDR implementation and introduce the concept of structured dialogue as a means to address uncertainties and provide clarity for manufacturers. They also delve into the importance of governance for Notified Bodies in assessing regulatory changes and ensuring compliance.

The expertise and qualifications of Notified Body personnel are emphasized, with a focus on their technical background, skills, and attitude. Manufacturers are encouraged to provide clear and comprehensive technical documentation to facilitate effective interactions with Notified Bodies.

The role of Team NB in harmonizing processes among Notified Bodies is discussed, along with the potential limitations of relying solely on MedTech Europe guidance, which represents industry perspectives and may not fully align with regulatory requirements.

Throughout the conversation, the panelists share their backgrounds and expertise in the IVD and medical device regulatory field, providing valuable insights into the complex landscape of EU regulations and the critical role played by Notified Bodies in ensuring compliance and market access for manufacturers.

Takeaways

1. Notified Bodies are essential for ensuring compliance and market access for IVDs and medical devices in the EU.
2. Manufacturers must navigate a challenging and evolving regulatory landscape, working closely with Notified Bodies to address uncertainties and maintain compliance.
3. Clear technical documentation, expertise, and harmonized processes are key factors in fostering successful interactions between manufacturers and Notified Bodies.
4. While industry guidance can be helpful, manufacturers must ultimately ensure their compliance with the official regulatory requirements.

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