NEW MDA5 – Mastering the Basics: Performance Evaluation Plans and Reports for IVDs

Description

Performance evaluation is a fundamental IVDR requirement and includes the development of a PEP and a PER. These documents are essential for demonstrating scientific validity, analytical and clinical performance. While the concepts of PEP and PER are not entirely new, their structure and content have evolved significantly under the IVDR. Despite their importance, there is limited structured guidance available for medical writers tasked with their development.
This workshop aims to help medical writers interpret regulatory requirements and translate complex technical data into well-structured and compliant documents. Participants will be guided through the structure and purpose of the PEP and PER, learn how to identify and present clinical evidence, and apply best practices in medical writing and data presentation. The session includes step-by-step guidance, and focused discussions to help attendees confidently contribute to IVDR performance evaluation documentation.
Participant profile: This workshop is intended for medical writers with regulatory writing experience, who are involved in—or planning to support—the preparation of Performance Evaluation Plans (PEPs) and Performance Evaluation Reports (PERs) required under the In Vitro Diagnostic Regulation (IVDR, EU 2017/746). Familiarity with the IVDR and clinical evidence is desired. Prior attendance at the Introduction to In vitro Diagnostics would be helpful, but is not a prerequisite.