IVDR Impact on Molecular Diagnostics - Part 1

IVDR compliance as a competitive benefit for MDx providers

It is safe to say that the new IVD regulation will introduce a new era for in vitro diagnostics, with improved safety, traceability, and transparency for patients on one hand, but with increased expectations from manufacturers on the other hand.

Read the case study

What you will learn:

The new EU IVD Regulations, the rationale behind it, and the key differences with the existing IVD directive.

How MDx companies can gather scientific, analytical, and clinical evidence as part of the clinical performance evaluation.

The impact on Post-Market Surveillance and Vigilance, and which additional documentation is required.

IVDR Impact on Molecular Diagnostics - Part 1

IVDR compliance as a competitive benefit for MDx providers

What you will learn:

Download the EU IVDR case study part 1