EMA Updates Q&A on Companion Diagnostics Consultation Procedure for Notified Bodies
The European Medicines Agency has updated its Questions & Answers document on the practical arrangements for the companion diagnostics consultation procedure submitted to EMA by notified bodies.
The document is dated 18 August 2026 and identified as EMA/619893/2022 Rev.4.
Purpose of the Q&A
The document provides practical guidance for notified bodies involved in the EMA consultation procedure for companion diagnostics.
It addresses key procedural questions, including how to submit a letter of intent, how to notify changes, how rapporteurs are appointed, who acts as EMA contact, how to request pre-submission interactions, how to submit the application and what fees apply.
Letter of Intent Through IRIS
EMA explains that the notified body should use the IRIS platform to notify the Agency of its intention to submit an application for an initial consultation on a companion diagnostic.
This should be done at least three months before the expected submission date, selecting submission type “Eligibility and letter of intent.”
Because the medical device manufacturer is responsible for paying EMA consultation fees directly, EMA also states that the manufacturer should request a customer account number through EMA’s Accounts Receivable service sufficiently in advance of the intended submission deadline.
Changes to Contact Person or Submission Date
For changes to the previously indicated submission date of an upcoming application, applicants should use the IRIS platform and select submission type “Notification of changes.”
For updates to the pre-submission product contact, the IRIS industry coordinator should update the information through the IRIS portal.
Rapporteur Appointment and EMA Contact
Following receipt of the letter of intent, EMA triggers the appointment of a Rapporteur by CHMP and CAT, and the applicant is informed of the outcome.
During the consultation procedure, the Product Lead is the primary EMA contact before submission and throughout the procedure until the CHMP Scientific Opinion. The Product Lead also serves as the main liaison between the Rapporteurs and the applicant.
Pre-Submission Interactions
EMA recommends early interactions between the notified body, device manufacturer and marketing authorisation holder or applicant for the associated medicinal product, where applicable.
Questions on timing, regulatory or procedural aspects can be sent by the notified body to the appointed Product Lead after receipt of the intention-to-submit letter and within two months of the planned submission. If additional guidance is needed, the notified body may request a pre-submission meeting with the Product Lead, Rapporteur, device manufacturer and medicinal product applicant or marketing authorisation holder.
Application Submission
EMA states that the eSubmission Gateway and eSubmission Web Client are mandatory channels for submitting applications to the Agency, including supplementary information requested during validation.
Registration on eSubmission Gateway and the eSubmission Web Client should be completed sufficiently in advance, as registration can take up to 20 days. EMA also notes that submissions should not be sent directly to national competent authorities by CD/DVD or CESP, as this may lead to validation issues and delays.
Timing of Companion Diagnostic Consultation
The notified body is advised to submit the companion diagnostic consultation application during the last phase of the evaluation of the Marketing Authorisation Application for the associated medicinal product.
EMA also advises the notified body and device manufacturer to liaise closely with the medicinal product applicant or marketing authorisation holder to understand the medicine evaluation phase, particularly when approaching the opinion stage.
Fees and SME Reductions
Although the notified body requests the consultation from EMA, the medical device manufacturer is responsible for paying the consultation fees directly to EMA.
EMA also notes that fee reductions are available for scientific services, including consultation procedures, for medical device manufacturers with SME status registered at the EMA SME office.
Impact on IVD Manufacturers and Notified Bodies
For IVD manufacturers developing companion diagnostics, and for notified bodies managing the consultation procedure, the updated Q&A reinforces the importance of early planning and coordinated communication.
Manufacturers and notified bodies should pay particular attention to:
IRIS letter of intent submission;
three-month advance notification;
EMA customer account number for fee payment;
updates to submission dates and contact persons;
CHMP and CAT rapporteur appointment;
Product Lead communication;
early pre-submission interactions;
eSubmission Gateway and Web Client registration;
timing with the associated medicinal product evaluation;
fee responsibility and possible SME fee reductions.
For manufacturers of companion diagnostics, the document highlights that regulatory planning must be aligned not only with IVDR conformity assessment, but also with the evaluation timeline of the associated medicinal product.
