Procedural Aspects for the Consultation to the European Medicines Agency by a Notified Body on Companion Diagnostics
This guidance document is intended to support notified bodies, device manufacturers, and medicinal product applicants by outlining the procedural steps required for the consultation process with the European Medicines Agency (EMA) regarding companion diagnostics (CDx), in accordance with Article 48(3), (4), (7), and (8) of Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR).
In all relevant cases, the notified body must obtain a scientific opinion on the suitability of the CDx in relation to the associated medicinal product(s). This opinion may be obtained either from a competent authority for medicinal products, as designated under Directive 2001/83/EC, or from the EMA itself. The opinion must be secured before the notified body issues an EU technical documentation assessment certificate for the CDx.
This document provides practical guidance on:
- The initial consultation procedure between a notified body and the EMA for a companion diagnostic medical device; and
- Follow‑up consultations when changes occur that may affect the performance, intended use, or suitability of the device with respect to the medicinal product(s), and which may require a supplement to the EU technical documentation assessment certificate.
Practical Recommendations
- Pre‑submission Activities:
The notified body must inform the EMA when initiating an evaluation procedure for a CDx. Additionally, the notified body is expected to submit an “intention to submit” letter at least three months before the anticipated submission date. This letter should include the planned submission date, device name, manufacturer, classification, intended purpose, related medicinal product(s), targeted indications, whether the submission concerns an initial consultation or a modification, and any reference to parallel medicinal product procedures, if applicable.
- Data Requirements and Application Dossier Format:
Each CDx consultation request must be submitted to the EMA using the designated application form available on the EMA website. The consultation should specifically address the suitability of the CDx for the concerned medicinal product(s), considering the intended use and performance characteristics claimed by the manufacturer.
The dossier must provide adequate information on the scientific validity or rationale for biomarker use, device measurement characteristics, development history, and analytical and clinical performance. For co‑developed devices, a summary of the data included in the Summary of Safety and Performance (SSP) and the Instructions for Use (IFU) is typically sufficient, as more detailed assessment occurs during the marketing authorization evaluation for the medicinal product(s).
Consultation Procedure with the EMA
Under Regulation (EU) 2017/746, the notified body acts as the applicant for the consultation procedure. The CHMP/CAT assessment follows a 60‑day schedule. When justified issues arise that prevent adoption of a scientific opinion, the timeline may be extended by up to 60 additional days. A final opinion will be issued by the end of the extended period, taking into account any clarifications provided by the notified body.
Upon completion of the evaluation, the CHMP/EMA issues a scientific opinion on the suitability of the CDx in relation to the relevant medicinal product(s). For ATMPs, the CHMP opinion is based on a draft CAT opinion. The notified body must consider this scientific opinion when making its certification decision and subsequently inform the EMA of the outcome.
There is no legal requirement for CDx consultation timing to coincide with the marketing authorization or indication extension process for the medicinal product. For co‑developed devices, early engagement between the notified body and the EMA is recommended to optimize submission timing. For devices already marketed under Directive 98/79/EC and transitioning to the IVDR, as well as for follow‑on devices, the CDx consultation may begin at any time according to the CHMP/CAT timetable and is expected to be independent of medicinal product procedures. When a single CDx is used with multiple authorized medicinal products, a single consultation procedure is recommended.
Post‑Consultation Phase
Per Section 5.2(f) of Annex IX of the IVDR, any changes to a CDx that influence performance, intended use, or suitability with the relevant medicinal product(s) must be reported to the notified body. The notified body must assess these changes and determine whether a supplement to the EU technical documentation assessment certificate is required, in which case the EMA must be consulted.
The EMA will provide its opinion within 30 days of receiving complete documentation relating to the changes. If the notified body determines that a new conformity assessment under Article 48 is necessary, a new initial consultation—following the 60‑day timeline—must be conducted.
Don’t miss out! Click here to stay in touch.
Categories
Recent Blogs
Get the latest updates from Vistaar
Previous Post
Next Post
CONNECT WITH US
Let's talk about how Vistaar can help you