Demonstrating State of the Art for In Vitro Diagnostic Medical Devices

IVD webinar series: Webinar 2 - 10 June 2025. Covering available industry guidance on state of the art for In Vitro Diagnostic Medical Devices.

Our subject matter experts will provide definitions of the SOTA

Addressing SOTA for performance evaluation plan, performance evaluation reports, summary of safety and performance.

Speakers

Speaker

Global Head, IVD

Speaker

Senior Technical Specialist and Scheme Manager

Join us for an insightful webinar series to educate professionals in the IVD medical device industry on demonstrating state-of-the-art practices.

In this session, we will look the regulatory requirements under the In Vitro Diagnostic Regulation (IVDR). Learn about the key transition timelines including deadlines for: having an IVDR compliant QMS, formal applications lodged, and formal written agreements signed with a Notified Body.

Hear our leading subject matter experts will provide a clear roadmap to navigate these requirements and ensure your devices are compliant.

Originally aired on 22 May 2025.

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This session covers key methodologies and best practices for developing Performance Evaluation Reports, PMPF, and PMS. Learn how to generate high-quality clinical evidence and avoid common pitfalls when demonstrating the performance and utility of your IVD devices.

Originally aired on 08 July 2025.

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As an IVD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market

It is critical to work with a trusted EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

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