IVD Clinical Performance Studies
Your IVD clinical performance study needs regulatory rigor and diagnostic-specific expertise, not a generic clinical trial approach. Qserve designs, manages, and executes CPS engagements that hold up under IVDR scrutiny and protect your submission timeline.
What is a Clinical Performance Study?
What is a Clinical Performance Study?
A Clinical Performance Study (CPS) is a prospective investigation under EU IVDR 2017/746 that establishes or confirms the analytical and clinical performance of an in vitro diagnostic device for its intended purpose. A CPS is diagnostic: it measures how accurately a device detects or measures a condition, not how a treatment affects a patient.
How does a CPS differ from a medical device clinical trial?
A CPS evaluates diagnostic accuracy. A clinical trial under EU MDR 2017/745 evaluates a device's therapeutic effect on a patient. Manufacturers searching for “IVD clinical trials” are usually looking for a CPS. The two terms get used interchangeably, but MDR and IVDR set separate legal pathways, evidence requirements, and competent-authority processes for each.
Why do CPS timelines slip?
Manufacturers running their own CPS most often lose time in a handful of predictable places:
- an unclear regulatory pathway across the countries where sites are running
- a study protocol redesigned mid-course to fix a design flaw an ethics committee flags late
- ethics committee and competent authority submissions that stall on missing documentation
- data integrity gaps discovered after site monitoring, not before it
- a mismatch between the clinical evidence generated and the performance claims in the technical documentation
What does IVDR require for a Clinical Performance Study?
IVDR Chapter VI (Articles 56 to 77) sets the legal framework for performance evaluation and performance studies. IVDR Article 57 defines the baseline requirements every CPS must meet. Article 58 adds obligations for studies involving intervention or additional invasive sampling, and Article 66 governs the application submitted to competent authorities and ethics committees before a study can start. Annex XIII (performance evaluation, performance studies and PMPF) and Annex XIV (interventional clinical performance studies) set out the detailed evidence requirements.
Sponsors also commonly draw on the good clinical practice principles in ISO 14155:2026 where IVDR itself is silent on procedural detail, even though the standard was written for MDR-side investigations rather than IVDs specifically.
Our CPS services cover multiple disciplines. Discover them:
CPS Authorization/Notification
We guide you through the Clinical Performance Study (CPS) authorization and notification process, ensuring compliance with local requirements and timely approvals.
Adverse Event Reporting
We ensure accurate and timely adverse event reporting during clinical studies, aligning with regulatory expectations and minimizing risk exposure.
CPS Amendments
We support you in drafting, assessing, and submitting CPS amendments to maintain regulatory compliance throughout the study lifecycle.
Regulatory Submissions (Ethics Committees/Competent Authorities)
We help prepare and submit comprehensive regulatory dossiers to Ethics Committees and Competent Authorities, facilitating smooth and efficient study approval.
Site Monitoring
We perform monitoring audits at study sites such as central labs to ensure compliance with the ongoing clinical performance study in every stage of the process.
Legal Representative
Qserve can be your legal representative in the European Union for the clinical performance studies it helps execute.
When do you need CPS expertise?
When do you need CPS expertise?
You need dedicated CPS support if you're bringing a new IVD to CE marking and haven't generated clinical performance data yet, if an existing study has stalled at an ethics committee or competent authority, or if a protocol amendment mid-study needs a fast, defensible turnaround.
Related reading
For the step after CE marking, our PMCF studies team picks up post-market performance follow-up. If your performance data feeds into a wider Performance Evaluation Report, see Clinical Evaluation and Performance Evaluation support. For broader outsourced study delivery beyond a single CPS, see our Contract Research Organization (CRO) services.
Still have questions?
Does every IVD require a Clinical Performance Study under IVDR?
Not always. Where existing clinical evidence — literature, data from an equivalent device, or an already-established analytical performance — is sufficient to support your performance claims, a full CPS may not be required. Classification and the strength of your existing evidence determine this, so it's worth confirming early rather than assuming either way.
How can delays in a CPS impact the success of an IVD product?
Delays push back your CE marking timeline directly, since the technical documentation can't be finalised without the clinical evidence a CPS produces. Beyond the timeline, a rushed or poorly documented study is also more likely to draw notified body queries later, adding a second round of delay on top of the first.
Can Qserve act as EU legal representative for a CPS run across multiple countries?
Yes. We can act as your legal representative for the clinical performance studies we help execute in the EU, which matters if you're a non-EU manufacturer coordinating sites across several member states with different competent authority requirements.
What are common causes of inefficiency in IVD clinical performance studies?
Delays often stem from unclear regulatory strategies, incomplete documentation, misaligned protocols, and poor coordination with Ethics Committees or Competent Authorities.
How can inefficiencies impact the success of an IVD product?
Inefficiencies can lead to missed deadlines, increased costs, and delayed market access, which can seriously risk commercial opportunities and compliance.
How does Qserve help ensure a smooth and compliant clinical study process?
Qserve offers end-to-end support by managing CPS submissions, handling regulatory communications, overseeing amendments and adverse event reporting, and ensuring all actions align with IVDR requirements.
Why should I partner with Qserve for my IVD clinical study?
With deep clinical and regulatory expertise, Qserve helps you design smarter studies, avoid costly mistakes, and accelerate time to approval, giving you a trusted partner in a high-stakes process.
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