IVDR for medical laboratories

In this seminar you will learn how to document and operate your in-house tests in an IVDR-compliant manner. You will learn to structure files and organize your schedule.

At the end of the seminar you will be able to classify your in-house test portfolio and create your individual IVDR schedule.

Goals

The aim of the seminar is to give you the ability to prepare your Laboratory Developed Tests (LDT) for IVDR.

This includes the following, amongst others:

• What are Laboratory Developed Tests? You will know the differences between tests from in-house production, Research Use Only Products (RUO) and CE-IVD tests and you will gain an overview of the current requirements for LDTs.
• What does the IVDR require for laboratories? We get a detailed overview of the LDT-specific requirements and understand their meaning and effects. You will learn which subject areas you need to prioritize when transitioning to IVDR.
• General safety and performance requirements: You will know which requirements apply to your in-house tests and you will learn how to show evidence that they have been met.
• Classification: You will get to know the fundamentally changed classification rules.
• Impacts on your quality management system: During the seminar we compare the requirements of the IVDR with those of ISO 15189. You will learn the methods of how to describe processes in a lean manner and how to achieve an efficient QM system.
• Performance Evaluation: You will learn the concept of performance evaluation to provide clinical evidence for your LDTs.
• Approaches for sampling sets: We show you how you can declare sampling sets as systems and procedure packs and thus have legal security and avoid unnecessary documentation.
• Use LDTs safely: We get an overview of the aspects of information security, surveillance, vigilance, software, risk management and usability required by the IVDR, and how you can orchestrate these processes.

Target participants

Participants can include:

• Laboratory physicians
• Laboratory management
• Employees from the areas of quality management and regulatory affairs
• Scientific or medical management
• Development and project management