According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal product, by identifying patients that are suitable or unsuitable for treatment.
We have already been talking about IVD devices and related topics, such as EU IVDR 2017/746, performance evaluation, stability of IVDs and much more.
For a more detailed definition, we need to take in consideration the In-Vitro Diagnostic Regulation EU IVDR 2017/746, the defines in companion diagnostic as “a device which is essential for the safe and effective use of a corresponding medicinal product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;
The IVDR introduces new requirements related to companion diagnostic IVD devices; in this article we will go into more details on these requirements.
Companion Diagnostic and the European Medicines Agency (EMA)
According to IVDR 2017/746, a notified body before issuing a CE certificate must seek a scientific opinion from EMA on the suitability of the companion diagnostic to the medicinal product concerned in the following situations:
- the medicinal product falls exclusively within the scope of the centralised procedure for the authorisation of medicines, or
- the medicinal product is already authorised through the centralised procedure, or
- a marketing authorisation application for the medicinal product has been submitted through the centralised procedure.
EMA has published different guidelines that define the practical aspects of this consultation activity:
- Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics: here ;
- Questions & Answers – Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies: here .
Practical Organization of Consultation for Companion Diagnostic
From practical point of view, the consultation activities is divided into different phases:
- Pre-submission phase. In this phase, the notified body is expected to provide an “intention-to-submit-letter” to the EMA at least 3 months before the planned submission date of request for a scientific opinion on the suitability of the CDx with the concerned medicinal product(s), using the relevant template that can be found on the European Medicines Agency website. In this phase, there enlighten be early interactions between the Notified Body, the manufacturer and the EMA, to ensure all the relevant information are properly shared among the different actors.
- Submission phase: application and scope. As mentioned within Annex IX of EU IVDR, the consultation will be based on the draft summary of safety and performance (SSP) and the draft instructions for use (IFU) of the device, as submitted by the notified body. The SSP shall be prepared according to Article 29 of IVDR whereas the contents of the IFU are summarised within Annex I, section 20.4.1. Where applicable, relevant guidelines from Medical Device Coordination Group (MDCG) shall be followed.
- Assessment phase: Development of scientific opinion. The EMA will provide its opinion within 60 days of the start of the procedure. If further clarification is needed to conclude on the suitability of a Companion Diagnostic (CDx) for use with the concerned medicinal product(s), a list of questions may be issued to be addressed by the notified body, and at their discretion with the involvement of the CDx manufacturer.
- Post-consultation phase. In case changes are made to a CDx that affect the performance and/or the intended use and/or its suitability in relation to (a) medicinal product(s), the manufacturer must inform the notified body of the changes. The notified body shall assess these changes and consult the EMA in the framework of a follow-up consultation in case it identifies the need for a supplement to the EU technical documentation assessment certificate or to the initial EU type-examination certificate.
Conclusions
In conclusion, we have provided an overview of the main requirements related to CE certification process for companion diagnostic IVD devices. Under certain conditions, this type of device shall undergo a specific process involving consultation between the notified body and the European Medicines Agency.
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