Companion Diagnostics IVDR and Companion Diagnostics FDA CDx

Regulatory consultancy support for the development of companion diagnostics

CDx regulatory requirements

Companion Diagnostics FDA and IVDR

Companion Diagnostics FDA and Companion Diagnostics IVDR (CDx), personalized medicine, and clinical trials assay (CTA) require specialized regulatory knowledge and practical experience. This sector is experiencing a multitude of changes as the technology evolves at the same time as the regulations are in flux; this includes:

  • Clinical Trial Regulation (CTR) in Europe
  • IVD Regulation in Europe
  • Changes to the classification of some CDx devices in the US
  • Transition of Lab Developed Test (LDT) in the US to FDA-cleared services as 510(k) or PMA.

All stakeholders are learning by doing. Our IVD experts have extensive experience working with both pharma and diagnostic partners in this sector, supporting both parties to help them work efficiently together. Not all assays used in clinical trials will become commercial IVD assays, and the Qserve team has experience in navigating this tricky area in both Europe and the US. Pictures/CDx 6 Phases2024.jpg?preset=content

The team provides regulatory consultancy support across the entire IVD product development lifecycle, from developing a clear strategy to supporting clinical trial assays of IVD clinical performance studies to the preparation of technical files for Europe or 510(k) or PMA regulatory submissions to bring the CDx to the US (Companion Diagnostics FDA) and European markets (Companion Diagnostics IVDR). 

Do you need help with your Companion Diagnostics FDA or Companion Diagnostics IVDR?

Qserve is your trusted partner to setup the regulatory strategy
and fulfill the Companion Diagnostic Process.

Contact us


Companion Diagnostic Process

Precision Medicine Clinical Trials & Diagnostic Development

As precision medicine diagnostics require the co-development of both drug and device, Qserve’s services are relevant to both the Pharma/Biotech and Diagnostic stakeholders. We have experience working with both pharma and diagnostic partners, large and small, to help fit the regulatory paths of both sectors to operate as efficiently as possible.

Qserve supports the companion diagnostic process:

  1. Diagnostic Strategy
  2. Diagnostic Partner Selection
  3. Diagnostic Product Development
  4. Clinical Performance Study | Investigational Device Exemption Submissions
  5. Clinical Performance Study Conduct
  6. Premarket Applications | Conformity Assessment Submission 

Qserve IVD CDx consultancy services

Companion Diagnostic Services

  • Strategic regulatory advice
  • Study design
  • Medical and technical writing
  • Technical documentation review
  • QMS support
  • Legal representative
  • Authorized representation
  • On-site or remote training
  • Ad-hoc support

Clinical Trial Assay (CTA)

Used in early-phase Pharma studies
  • Advise on CTA performance study authorization requirements and process per country
  • Advise or draft clinical performance protocol
  • Analytical study designs, protocols, reports
  • Bridging study design

CDx consultancy

Qserve is an expert in CDx consultancy. We support global medical technology companies worldwide to market their innovative technology and solutions that help patients and healthcare providers in Europe and the US.

We offer US and EU-based staff, sharing all the insights into the EU-IVDR regulation and US FDA IVD requirements. 

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Who can we help?

CDx and CTA can require support from multiple disciplines. Qserve has the advantage that it can support customers not only with IVD design and regulatory support but also has business units to support medical devices, software including AI and quality management systems (QMS) including ISO 15189 and CAP/ CLIA. We also have a medical device CRO and can support applications for clinical studies in Europe and US, making Qserve an ideal partner to engage with.

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CDx | Super IVD or not?

The field of personalized medicine is a new and evolving field with new combinations of products and new terms to understand. A lot of work is being done on what is called companion diagnostic (CDx) in the IVD world. 

Explore what companion diagnostics are and how they differ from other diagnostics, including some points to consider if tasked with developing one. 

Read blog

CDx guidance for EU-IVDR

There are a lot of questions raised about IVDR CDx guidance because IVDR is still a huge mystery for companies. The EU-IVDR defines companion diagnostics as devices that are essential for the safe and effective use of corresponding medicinal products to identify patients who are most likely to benefit. 

Companion Diagnostics and Personalised Medicines are advancing at the same time as the regulations to support them in Europe evolve. This is challenging for not only the pharma and diagnostic partners but all stakeholders. 

Specific IVDR CDx guidance

  • IVD Clinical Performance study design, plans and reports
  • In-house tests (distance sales, exemptions)
  • Conformity assessment route to CE Mark (Class C)
  • CE certification of CDx
  • Notified Body selection
  • Notified Body review process, including EMA coordination of drug approval application (CTR)

Annex XIII and Annex XIV

  • Guidance and interpretation
  • Gap assessments and remediation
  • Write Clinical Performance Study Plans (CPSP) and Reports

CDx guidance for US FDA CDx

Qserve can support early engagements with regulators by contributing to the description of the diagnostic strategy in FDA IND and pre-submissions. Qserve’s team has previous experience in sponsoring regulatory submissions for approval of the use of investigational devices within precision medicine clinical trials. 

Our experts guide FDA pre-submissions relating to clinical trial assay and CDx product development, which can be used to support diagnostic providers in their engagements with the FDA and other competent authorities. 

Specific US CDx guidance:

  • Regulatory consulting on pre-submissions
  • FDA IDE and significant risk determination
  • Proposed rule for the transition of LDT to 510(k) or PMA submission
  • 510(k), CDx PMA submission
  • Innovative trial designs