CONNECT seminar: The new EU regulations on IVDR – how to be prepared?
Updated: May 12, 2022
Here you will find two presentations held at a recent CONNECT meeting. The speakers explain how the new EU regulations on In Vitro Diagnostic Medical Devices (IVDR) work and what challenges the industry is facing with the new regulations.
The seminar starts withs some hard facts. What is IVDR? What is the purpose of it, and why do we in Norway need to follow these regulations?
The first presentation is by Mohsen Shadidi from the Oslo University Hospital. He gives an introduction to EU In Vitro Diagnostics Regulations and status of the adaptation.
But what about the pharmaceutical industry? How are they affected by the new regulations? In the second presentation Tove Ofstad from Roche Diagnostics Norge AS discusses various drivers for the change and asks how the industry needs to adjust to meet the new requirements. What is challenging? What is the status now when there is less than one year left to implement?
We do what we can. Forget the Roche logo on the slide - the whole industry is doing what we can to reach our goal.
Tove Ofstad, Roche Diagnostics
About the speakers
Mohsen Shadidi, Head of section for Molecular Diagnostics, Department of Pathology, at Oslo University Hospital. Shadidi is a molecular biologist by education and has conducted cancer research both as a research fellow and postdoc.
Tove Ofstad, Market Access and Business Development Manager, Roche Diagnostics
Norge AS. Ofstad is a bioengineer who has worked in the primary health service in meetings with patients, has experience from laboratory work and further 28 years of experience from the health industry.
See the video of the presentations
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We would like to say a big thank you to the speakers, stakeholders and all the participants at the seminar!