PV Bulletin

Updated Companion Diagnostics Consultation Procedure by EMA

The European Medicines Agency has clarified the practical arrangements for companion diagnostics consultation procedures with notified bodies, emphasizing submission timelines and process details.

Primary source: European Medicines Agency (EMA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

The document specifies that notified bodies must submit a letter of intent at least three months prior to the intended submission date for companion diagnostics consultations. Additionally, submissions must be made via the eSubmission Gateway and eSubmission Web Client.

Why it matters

Understanding these updated consultation procedures is essential for ensuring that the safety data of drug and diagnostic combinations are properly assessed during regulatory reviews, which is crucial in the context of medical device vigilance and companion diagnostics.

Action needed

Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Q&A
Policy status
revised
Publication date
2026-08-19
Policy change
This Q&A document clarifies the practical arrangements for the consultation procedure between Notified Bodies and the EMA regarding companion diagnostics. It has been updated to provide further detail on the interaction and the documentation required for the scientific opinion process.

Key changes

Clarifications on the consultation process for companion diagnostics (CDx) under the Medical Device Regulation (MDR). Provides tracked changes for transparency on the latest procedural refinements.

Affected workflows

Country Compliance

Responsible groups

Regulatory AffairsMedical Device VigilancePharmacovigilance

PV impact

While primarily focused on the interaction between Notified Bodies and EMA, PV teams involved in medical device vigilance or products with companion diagnostics should review these arrangements. Understanding the consultation procedure is critical for ensuring that safety data for the combined use of the drug and diagnostic is adequately assessed during the regulatory review.

View regulator source

Source document details

Exact policy details

Notification of Intent
At least three months in advance of the expected date of submission.
Applies to: Notified Bodies submitting an initial consultation application.
Section 1 · p. 3 · High · Source
Submission Requirements
Submissions must be made via eSubmission Gateway and eSubmission Web Client.
Applies to: All applicants submitting applications to EMA.
Section 6 · p. 4 · High · Source
Account Number Request
Request should be made sufficiently in advance of the intended submission deadline.
Applies to: Medical device manufacturers.
Section 7 · p. 5 · High · Source

Workflow rule impacts

Country ComplianceNotified Bodies and Medical Device Manufacturers.

Increased reliance on the IRIS and eSubmission platforms for compliance checks.

Mandatory use of specific submission platforms.

Sections 1, 6 · p. 3 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Aug 19, 2026

Full briefing

Practical implication

Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

A new Q&A document from the EMA outlines the practical arrangements regarding the consultation procedure between Notified Bodies and the EMA for companion diagnostics. Important details include a three-month notice requirement for submitting a letter of intent and the mandatory use of the IRIS platform for such notifications.

What changed: The document specifies that notified bodies must submit a letter of intent at least three months prior to the intended submission date for companion diagnostics consultations. Additionally, submissions must be made via the eSubmission Gateway and eSubmission Web Client.

Why it matters: Understanding these updated consultation procedures is essential for ensuring that the safety data of drug and diagnostic combinations are properly assessed during regulatory reviews, which is crucial in the context of medical device vigilance and companion diagnostics.

Practical implication: Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Country Compliance#European Medicines Agency (EMA)#revised#policy-change#Guidance#firecrawl-policy-agent#Q&A

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