Understanding Regulatory Requirements & Standards Deadlines

IVD webinar series: Webinar 1 - 22 May 2025. This webinar will focus on the regulatory requirements under the In Vitro Diagnostic Regulation (IVDR).

Here from our leading experts on the subject matter

Learn about key transition timelines including deadlines for: having an IVDR compliant QMS, formal applications lodged and formal written agreements.

Speakers

Speaker

Head of IVD Medical Devices Notified Body BSI

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

Learn how to define and apply state of the art (SOTA) in line with current industry guidance. This session covers how to address SOTA in the Performance Evaluation Plan, Performance Evaluation Reports, and Summary of Safety and Performance.

Originally aired on 10 June 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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