Deep Dive into the IVDR (In-Vitro Diagnostic Regulation) Annex XIII In-house Training

Course overview

Understand where, when and how performance evaluation should be undertaken during the life cycle of an IVD device under the IVDR (2017/746).

The EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, came into force in May 2017, with an initial transition period of five years, and an intention to strengthen the current approval system for in vitro diagnostics in Europe through an evidenced based Notified Body review system. A key area of change is the minimisation of self-certification, and the introduction of mandatory documentation for the planning and reporting of the manufacturer’s clinical evidence to demonstrate the safety and effectiveness of the IVD device under evaluation.

IVDeology and Management Forum have developed a highly interactive training programme to provide a deep-dive into the nine documents mandated in Annex XIII - Performance Evaluation, Performance Studies and Post-market Performance.

We shall answer what information is required, where to put it and when. The primary documents we will review are as follows:

• Performance Evaluation Plan
• Scientific Validity Report
• Analytical Performance Report
• Clinical Performance Study Plan
• Clinical Performance Study Report
• Clinical Performance Report
• Performance Evaluation Report
• Post-Market Performance Follow-up Plan
• Post-Market Performance Follow-up Report

This course is part of our range of Medical Devices training courses

Benefits of attending

• Gain a comprehensive overview of documents mandated within Annex XIII of the IVDR
• Enhance your understanding of key concepts used within IVDR performance evaluation
• Understand the purpose and scope of each document and their interrelationships
• Learn how to draft documents to assist Notified Body reviews

Who should attend?

Professionals involved in the research, development, or manufacturing of in vitro diagnostic medical devices, including: 

• Senior management
• Regulatory affairs personnel
• Quality assurance professionals
• Product development personnel
• Project managers
• R&D personnel
• Clinical performance study personnel
• Pharmaceutical/CRO clinical trial managers