EMA publishes Guidance on Companion Diagnostics

As May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body.
The 10-page document describes how the consultation procedure between the EMA and a Notified Body should be conducted when it comes to companion diagnostics. Reference is made to Article 48 (3.4.5 and 8) of the IVD Regulation 2017/746.

According to the IDR (Article 2.7), companion diagnostic means a device that is essential for the safe and effective use of an associated medicinal product in order to

  • (a) identify patients before and/or during treatment who are most likely to benefit from the associated medicinal product

  • (b) identify patients before and/or during treatment who are likely to be at increased risk of serious adverse reactions as a result of treatment with the associated medicinal product.

The consultation procedure is a scientific consideration by a Notified Body of the appropriateness of a therapeutic diagnostic with the medicinal product towards the EMA or an authority designated by the EMA. Depending on the type of marketing authorisation and the marketing authorisation status, there are different ways. An initial consultation procedure and a "follow-up" consultation procedure in case of changes are described.

The practical recommendations describe:

  • Pre-submission activities
  • Data requirements and format of the application dossier
  • Consultation procedure to the EMA
  • Post-consultation phase
  • Fees

Regarding fees, reference is made to further EU documents and a corresponding EMA website. Fee reductions may be applied to small companies within the framework of a "scientific service". Finally, the chapter on references ends the draft document with links to two directives and the IVDR.

The draft entitled "Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on
companion diagnostics
" is open for comments until 20 February 2022.

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.