Deadline to be IVD-R compliant is 26th May 2022 - What does it mean for the clinical laboratories?

Deadline to be IVD-R compliant is 26th May 2022

What does it mean for the clinical laboratories?

What will change for the non-commercial tests developed by the laboratories?

The IVD-R does not only raise the bar higher for manufacturers, but for the complete IVD ecosystem including clinical laboratories that were not affected by the IVD-D but are in the scope of IVD-R.

Clinical laboratories will indeed need to be compliant with IVD-R for the IVD assays they develop and manufacture within their laboratories, often called Laboratory Developed Tests (LDTs).

While the IVD-R acknowledges the need for LDTs to diagnose specific pathologies - as there are no CE-marked and commercially available assays for all disease areas - it also understands the risk associated with under controlled, high-risk LDTs.

This webinar is dedicated for biologists, physicians, quality, regulatory and general managers of a clinical laboratory.

You will learn :

• What are the differences between the IVD directive (98/79/EC) (IVD-D)?
• How it impacts the clinical laboratories?

We will give special attention to the Laboratory Developed Test (LDT’s) which are often used in flow cytometry.

Thanks to our experts for joining us to share their experience and knowledge. They will deal with the main challenges of IVD-R for laboratories and compliance impacts.

OUR EXPERTS:

Brice EZZOUAOUY, Senior Product Manager, Beckman Coulter Life Sciences:

"EU IVDR regulation: understanding the new requirements for a smooth transition"

Maurizio SUPPO, Vice-President of QARAD European Regulatory Services - Experienced in the IVD and MD field since 1986, Qarad is a team of experts, specialized in Regulatory Affairs and Quality Systems for the IVD and Medical Devices.