Deep Dive into the IVDR Annex XIII
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
Special offer:
Expand your understanding of IVDR requirements by also attending our 'Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)' course. This training provides a comprehensive overview of performance evaluation throughout the life cycle of an IVD device, essential for ensuring regulatory compliance.
Sign up for both and receive the second course at 50% off. Please contact us at info@ipi.academy to take advantage of this offer.
Upcoming start dates
Suitability - Who should attend?
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
Request information - obligation free
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
About IPI Academy
International Professional & Industry Academy (IPI) is an international leading professional training organisation based in London. Our training solutions provide a return on your investment with measurable results, and are delivered by experienced professionals and managed with exceptional care and...