The new EU IVD regulation will introduce major changes that will greatly impact IVD product development and CE marking. These changes will introduce delay to market access and increased cost to CE marking IVD medical devices in Europe. As an example, there will be a premarket review of technical dossiers by a Notified Body for the majority of the devices.

In particular, companion diagnostics (CDx) will be classified as high risk devices which would necessitate the involvement of Notified Bodies prior to CE Marking, unlike the current situation. This regulatory body will assess the CDx documentation and the manufacturers’ quality system before issuing the EC design examination certificate.

However, this premarket review of IVD/CDx documentation and manufacturer’s quality system might provide more recognition of the CE mark outside Europe where CE mark of IVDs is today considered a low value, as CE self-certification applies to the vast majority of IVDs, including CDx.

This presentation describing the new EU regulatory framework for IVDs and companion diagnostic will discuss some essential topics related to CE marking according to the new EU requirements: device classification and conformity assessment, the importance of the demonstration of the clinical evidence to be included in the CE technical documentation, future interactions between the EMA and the Notified Bodies involved in CE marking of CDx.

Key learning objectives:

  • Understanding the future EU IVD regulatory framework
  • Key development activities for CE marking IVDs/CDx
  • Regulatory challenges to overcome for CE marking CDx

Keywords: In vitro diagnostic medical device (IVD), companion diagnostic (CDx), IVD regulation, CE marking, EU IVD regulatory framework, Notified bodies


Sylvie Le Glédic, Director Medical Devices & IVD

She is actively involved in the evolution of the EU IVD and MD regulations, and closely follows the new rules for regulatory approval of Companion Diagnostics (CDx), both in EU and US.

Christophe Amiel, Senior Director Medical Devices & Digital Life Sciences

Christophe Amiel is heading the design and implementation of regulatory strategy as Senior Director within Voisin Consulting Life Sciences for medical devices (including in vitro diagnostics), digital life sciences, as well as combination products (drug-device association) including activities related to Clinical Trials Application and vigilance.

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