Regulations for Companion Diagnostics in the US and EU

Download our white paper on Overview of Regulations Governing Companion Diagnostics in the US and EU

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Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision medicine. Second, they come with some unique regulatory challenges because they are considered pharmaceuticals and medical devices.

The United States and Europe take a unique approach to regulating these innovative devices. In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.

What you will learn in this 5-page white paper:

  • How have regulations for CDx products evolved over time?
  • How do regulations in the US and Europe apply to CDx products?
  • How to time drug and diagnostic approvals?
  • What business and development obstacles do I face with a CDx product?

We answer all of these questions and many more in this white paper.

About the Author:

Oliver Eikenberg, PhD is Senior QA/RA Consultant at Emergo's office in Hamburg, Germany. His areas of expertise include QMS implementations and regulatory submissions in the US and Europe, particularly for IVDs in the areas of neurology, infectious disease, autoimmune disorders, cancer, genetic markers, and CDx. He holds a PhD in chemistry from the Technical University of Munich.

Major Regulations
Document Number Published Language
Download IVDR White Paper 12/02/2021
Log in Council Directive 90.385.EEC (AIMDD) 90/385/EEC 06/1990 English
Log in Council Directive 93.42.EEC (MDD) 93/42/EEC 06/1993 English
Log in Council Directive 98.79.EC (IVDD) 98/79/EC 12/2011 English
Log in Regulation (EU) 2017.746 (IVDR) 2017.746 05/2017 English
Log in Regulation (EU) 2017.745 (MDR) 2017.745 05/2017 English
General Guidance Documents
Document Number Published Language
Log in MDCG Guidance Documents English