Best Practices for Performance Evaluation Reports PMPF/PMS

IVD webinar series: Webinar 3 - 8 July 2025 - Methodologies & best practices for demonstrating clinical utility & effectiveness of your IVD devices.

Focusing on aspects of Performance Evaluation Reports/PMPF/PMS

Our experts will share best practices and common issues to help you design robust validation studies and generate high-quality evidence for your IVD.

Speakers

Speaker

Technical Specialist and Scheme Manager, BSI

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.

Watch the Webinar
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.

Watch the Webinar
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.

Find out more