IVD Clinical Performance Studies That Drive Global Regulatory Success
Expert-led clinical performance evaluation for IVDR, FDA, and global markets-with comprehensive protocol development, site management, ethics committee submissions, and regulatory documentation.
Why IVD Clinical Studies Matter
Successful IVD clinical performance studies are critical for market access under IVDR, FDA, and global regulatory frameworks.
Whether you’re developing a high-risk Class D assay, a companion diagnostic (CDx) , or transitioning from IVDD to IVDR, MDx CRO ensures your clinical evidence meets regulatory expectations through rigorous clinical performance evaluation and strategic study design.
Our team delivers end-to-end clinical study solutions -from IVDR Annex XIII/XIV submissions and clinical performance study protocols (CPSP) to site management, ethics committee approvals, and final clinical performance reports. With expertise in ISO 20916 and IVDR compliance, we ensure your IVD receives timely approval with robust clinical evidence.
Full-Service Clinical Study Design & Execution
- IVDR clinical strategy and pathway
- Clinical performance study design (CPSP)
- Feasibility and study risk assessment
- ISO 20916-aligned planning and timelines
- CPSP development
- Annex XIII/XIV evidence planning and alignmen
- Ethics Committee / IRB submissions and packages
- Competent Authority documentation and interactions
- Investigator’s Brochure creation
- EUDAMED performance study notifications
- TMF setup and maintenance
- Site and lab selection, qualification, and initiation
- Investigator training and site initiation visits
- Clinical monitoring (on-site and remote) to ISO 20916
- Biological sample logistics and accountability
- CRF/eCRF design, build, and implementation
- Protocol adherence oversight and issue resolution
- eCRF design and validation; data capture and QC
- Statistical analysis plan development and execution
- Clinical performance reports; final clinical evidence packages
- Device deficiencies tracking and reconciliation
- TMF completeness checks and close-out
- Adverse event monitoring and safety reporting for performance studies
- Ongoing regulatory authority communications
- Coordination with Notified Bodies
- EU Legal Representative for non-EU sponsors;
- UK RP for non-UK sponsors
- Multi-country study harmonization
Regulatory Alignment
MDx ensures your IVD clinical studies comply with all relevant regulations:
- IVDR 2017/746 – Annex XIII, Annex XIV, Article 58, 61-69
- ISO 20916:2024 – Clinical performance studies for IVDs
- FDA requirements for IVD clinical studies
- ISO 14155 principles where applicable
- GCP principles adapted for IVD performance studies
- Local ethics committee requirements
- National Competent Authority requirements
Study Types We Support
Clinical Performance Studies
Scientific (peer-reviewed) literature
Data based on routine diagnostic testing
Post-Market Performance Follow-up (PMPF)
Performance Evaluation
Companion Diagnostic (CDx) Studies
Method Comparison Studies
| Technology |
|---|
| Molecular Diagnostics |
| Immunoassays |
| Histopathology |
| Point-of-Care |
| Software & AI |
| Applications |
|---|
| PCR, qPCR, digital PCR, NGS panels |
| ELISA, chemiluminescence, multiplex |
| IHC, ISH, digital pathology |
| Lateral flow, microfluidics, biosensors |
| Algorithm validation, SaMD, digital diagnostics |
| Capability |
|---|
| ISO 20916 Study Design |
| IVDR Clinical Evidence Expertise |
| Ethics Committee & CA Submissions |
| Performance Study Monitoring |
| Legal Representation in EU |
| IVD-Specific Documentation |
| EUDAMED Registration |
| MDx CRO | Other CROs |
|---|---|
 Specialized expertise |  Limited experience |
| Former NB/CA experts | Often lacking |
| 100% success rate | Variable experience |
| IVD-specialized monitors | Often pharma-focused |
| Full service available |  Rarely offered |
| CPSP, performance reports | Generic templates |
| Complete support | Limited guidance |
Frequently Asked Questions
Ask us a Question- What is the difference between a clinical trial and an IVD performance study?
While both evaluate device performance, IVD performance studies follow specific regulations (IVDR, ISO 20916) rather than traditional clinical trial frameworks (ICH-GCP). IVD studies typically focus on evaluating an assay’s clinical performance using existing or newly collected samples, rather than testing interventions on patients.
- Can MDx handle ethics committee and competent authority submissions?
Yes, we manage all aspects of ethics committee (EC/IRB) submissions and competent authority applications. Our team has a 100% success rate in obtaining approvals across multiple European countries for IVDR performance studies.
- Does MDx offer legal representation for IVD clinical studies in Europe?
Yes, we provide full legal representation services for non-EU sponsors conducting studies under IVDR Article 58. This includes handling all regulatory communications, safety reporting, and compliance responsibilities.
- What is a CPSP under IVDR?
A Clinical Performance Study Protocol (CPSP) is a mandatory document for IVD performance studies under IVDR. It details study design, objectives, participant selection, sample handling, statistical analysis, and quality procedures in compliance with ISO 20916 and IVDR Annex XIII/XIV requirements.
- How does MDx handle safety reporting in IVD performance studies?
We implement robust systems for monitoring and reporting adverse events and device deficiencies according to IVDR requirements, with clear escalation pathways, reporting timelines, and documentation procedures.
- Can you support multi-country IVD studies?
Absolutely. We have extensive experience coordinating studies across multiple countries, harmonizing submissions, and managing site networks throughout Europe, North America, and APAC.
Partner with Europe's Leading IVD Clinical Study Experts
Whether you’re planning your first IVDR performance study or managing a global clinical evaluation program, MDx delivers the expertise, resources, and regulatory knowledge to ensure success.
From Protocol to Performance Report. We Deliver.
