What you have to do now and in the future to comply with the IVDR specifications for your in-house tests or lab developed tests (LDT).

As a laboratory doctor, technical expert, scientist, quality manager or laboratory manager, are you currently responsible for documenting your test portfolio in accordance with the IVDR in accordance with the law?

It is then your job to identify the applicable requirements, review existing documents and create new documentation to demonstrate compliance. You would like to find out which requirements of the IVDR apply to you as a medical laboratory and with which priority they are to be implemented and you need a reliable schedule.

You must already meet the essential safety and performance requirements according to Annex I and create a file on the design, manufacture and use of your in-house tests by May 26, 2024 at the latest.

If you want to make sure you interpret the requirements correctly and have all the points that apply to you on screen, we have a solution for you. Our seminar especially for medical laboratories offers you the perfect basis so that you know the activities required for implementation and can prioritize them correctly.

In this seminar you will learn

  • what requirements you have to meet,

  • when you need to meet these requirements,

  • how to document and operate your in-house tests in compliance with IVDR,

  • how you can structure the LDT files and

  • to 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 based on a developed timetable.

Goals

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

This includes, among other things, the following:

  • 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 will gain an overview of the previous national requirements for LDT.
  • What does the IVDR require from laboratories? We get a detailed overview of the LDT-specific requirements and understand their meaning and implications. You will learn which subject areas you need to prioritize when fulfilling the IVDR.
  • Basic security and performance requirements: You will know which requirements apply to your in-house tests and learn how to demonstrate compliance.
  • Classification: You will learn the classification rules in order to be able to proceed risk-based.
  • Effects on quality management: During the seminar, we compare the requirements of the IVDR with those of Rili-BÄK and ISO 15189. You will learn the methods of how to describe processes leanly and thus achieve an efficient QM system.
  • Performance Evaluation: You will learn the concept of performance evaluation to provide clinical evidence for your LDTs.
  • Solution approaches for sampling sets: We show you how to declare sampling sets as treatment units and thus have legal certainty and avoid unnecessary documentation effort.
  • Software: You know the ways to compliant documentation of formulas, algorithms, self-developed software and CE-IVD software as well as the software environment.
  • Using LDTs safely: We get an overview of the monitoring, vigilance, risk management and usability aspects required by the IVDR and how they orchestrate these processes.

KONTAKT:
Online Seminar

 

Mehr Informationen