EU IVD regulations now align with US. Are you ready?

Across the European Union, Notified Body (NB) review is now required—along with significant technical and quality documentation. The transition to this new paradigm may begin as soon as Q4 2017, and it will have a meaningful impact on product launch plans and timelines.

Companies need to start planning now to avoid market interruption. Precision experts can help. In the Precision Brief Perspective: New European IVD Regulations—New Concepts for Market Authorizations and Product Launch Schedules, our experts share guidance on how to optimize study designs and documentation to meet the demands of both the EU IVDR and the FDA, creating efficiencies in data, resources, and timelines.

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    Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.