The new legislation means big changes for most of the industry, with much stricter requirements for both the business and its products. With a new risk-based classification, the majority of companies are expected to need a Notified Body for conformity assessment and CE marking of products. Another major change is the increased demand for clinical evidence and a greater need for performance studies, which in many cases may require regulatory approval. Similarly, much more extensive monitoring and reporting of the safety, performance and clinical benefit of products will be required, with the European database EUDAMED playing an important role.
Training objectives
With this training we want you to get to know the IVDR, the requirements for IVD products and your obligations as a manufacturer. The course aims to provide knowledge of the requirements for IVD products and a roadmap for CE marking.
Course content and structure
Susanne Grimsby and Katarina Holmström lead the course and cover the IVDR as a whole, its structure and content with a focus on:
– New rules for classification
– Performance evaluation and clinical evidence
– Technical documentation and assessment
– Standards and guidance documents
– Post market surveillance
– Quality management system
Andreas Stange, VP at TÜV SÜD – one of Europe’s largest Notified Body for medical devices – will participate and talk about their experiences on assessment, “lessons learned” and “dos and don´ts”. This lecture will be held in English but other program items will be held in Swedish.
Finally, we will hear Carina Magnusson from one of the major IVD companies, Thermo Fisher Scientific, about their journey towards the IVDR, its challenges but also opportunities.
For networking and interaction, there will be space for questions, discussions and exercises.
Check the course page here for more information and registration.
