The course is aimed at those working in in vitro diagnostics and want to learn more about the new IVDR regulation.
In May 2022, the old EU In Vitro Diagnostic Directive (IVDD) was replaced by the new (2017/746) In Vitro Diagnostic Regulation (IVDR) to which the in vitro diagnostic industry is subject.
This course gives you an introduction to the new IVDR regulatory framework, including risk classification of in vitro diagnostic devices, quality management system and technical documentation requirements, and the process of CE marking with a notified body. You will gain knowledge about application areas, risk classification, the role of the Notified Body, the content of the technical documentation including clinical evidence requirements, post-market activities, risk management and safety requirements and different ways of demonstrating compliance with applicable legal requirements. Note: the training covers only IVDR, not IVDD.
After the training, you should have gained knowledge of the IVDR Regulation, the quality management system for in vitro diagnostics, risk classification of IVD devices, technical documentation and notified bodies.
Our instructor-led courses are carried out by our most sought-after consultants as educators. Classroom days are complemented by online training, so you can still meet others with similar challenges even when you are unable to travel or be away from work.
If instructor-led course dates are missing for the course you want to attend or if you want to customize a course for your specific needs, you can contact us and together we can find the best solution for you.
Most of the instructor-led courses are organized with our partners
Läkemedelsakademin (The Swedish Academy of Pharmaceutical Sciences), Swedish Medtech & Swedish Labtech.
|Instructor-led course can be done on request|
Dates for planned courses can be found in the calendar or on the right side of this page.
Essentials is for those who want to get a brief overview of a topic without in-depth training and tests. Our Essentials trainings are on average about 15 minutes long and do not include tests/certificates.
Principles is for those who want a basic course in a subject. Provides a good foundation for learning more and includes the "Essentials of".
Advances of is for those who want to gain an in-depth understanding of a topic. Here we recommend that you already have basic knowledge in the area or have completed our "Principles of" training in the area.
|Essentials of IVDR|
|Principles of IVDR|