Primary source: European Medicines Agency (EMA)
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.
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.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
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.
Increased reliance on the IRIS and eSubmission platforms for compliance checks.
Mandatory use of specific submission platforms.
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.
Published from the Firecrawl policy change extraction pipeline.
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