Navigating the IVDR CDx Certification Pathway

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The evolving landscape of Companion Diagnostics (CDx) introduces complexities in regulatory and certification processes. Engaging in IVDR Companion Diagnostic Consulting is essential to ensure a streamlined and compliant journey.

Deciphering Regulatory Nuances: US vs. EU

Historically, CDx devices in the EU were self-certified under the IVDD. A CDx manufacturer may have had experience with the FDA but the regulatory process in the EU is only now emerging.

The EU IVDR defines a CDx 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
• Patients likely to be at increased risk of serious adverse reaction as a result of treatment with a corresponding medicinal product

The FDA’s definition is similar but extends to devices used for “monitoring treatment responses with a particular therapeutic product”. Unlike in the US such devices are not considered companion diagnostics in the EU. Furthermore, the FDA acknowledges a category of devices termed complementary diagnostics. These diagnostics are characterized as tests that pinpoint a group of patients, identified by specific biomarkers, who respond well to a drug. While they assist in evaluating the risk-benefit ratio for individual patients, they aren’t mandatory for drug administration. Within the IVDR framework, complementary diagnostics aren’t explicitly detailed, nor do they have specific prerequisites for CE certification

These nuances are key for any CDx regulatory strategy and for the planning of CDx clinical trials. A specialized IVDR CDx consulting company like MDx CRO can help diagnostic companies and their pharma partners navigate global differences and ensure CDx regulatory compliance.

The EMA Consultation Process

EMA’s guidance stands as a pivotal component in IVDR Companion Diagnostic Consulting. The EMA CDx Assessment Report Template, publicly available, provides a comprehensive blueprint. It is a great source of information for the expectations in CDx submission content, particularly useful for when drafting SSPs and IFUs.

MDx CRO published a comprehensive guide to the CDx consultation process.

The process encompasses:

• Declaration of intent.
• EMA Rapporteur appointment.
• Optional, but highly recommended, pre-submission meeting.
• Application submission.
• Interactive Q&A phases.
• EMA’s final verdict.

Crafting of SSP & IFU with Detail

For successful IVDR CDx certification, the SSP and IFU documents should be meticulously detailed as they are the 2 key documents used during the EMA consultation process.

Diagnostic manufacturers should ensure they include:

• Emphasis on scientific validity of the biomarker
• Comprehensive detail on performance evaluation, study design descriptions, encompassing both analytical and clinical performance.
• Insight into clinical data, detail on device modifications during or after the clinical performance study, and associated impacts, rationale for cut-off point selection and more.

A deep dive into the risk-benefit analysis is pivotal, concentrating on major residual risks and device limitations.

Time Considerations for IVDR CDx Certification

The certification process for CDx under IVDR is extensive. From the initial 3-month EMA notification to the concluding recommendation, the timeline can span 8-18 months. Such extended durations underline the criticality of early preparations. Engaging early with a specialized CDx consulting company can help avoid surprises and streamline the CDx certification journey.

The expertise offered by the notified body can significantly enrich IVDR Companion Diagnostic certification. Early engagements, prior to document submissions, can provide clarity, ensuring alignment with EMA requirements.

Selecting your IVDR CDx Consulting partner