Definition of IVD Devices and Manufacturer Responsibilities
An in vitro diagnostic (IVD) medical device is any product—including reagents, kits, calibrators, instruments, or software—used for the analysis of biological specimens (e.g., blood, urine, saliva) outside the human body. Its purpose is to provide diagnostic, prognostic, or monitoring information. Every IVD must be certified under the IVDR before being marketed in the EU. The manufacturer is fully responsible for its quality, safety, and regulatory compliance.
Performance Evaluation of IVD Devices
Performance evaluation encompasses analytical, clinical, and scientific performance verification. Its purpose is to confirm that the device performs as intended and provides reliable results correlating with the patient’s clinical condition. According to the IVDR, this process must be documented as part of the IVD performance evaluation.
IVD Device Qualification and Classification
Accurate classification under IVDR determines the necessary level of oversight and the applicable conformity assessment procedure. IVDs are classified into classes A, B, C, and D—with class D representing the highest risk, such as HIV or HCV tests. Misclassification may result in rejection by the notified body.
IVD Study Feasibility Analysis
Before initiating a study, a feasibility assessment is required, considering sample availability, target population, laboratory infrastructure, and local legal compliance. Pure Clinical supports manufacturers in designing realistic and compliant study plans.
Medical and Technical Documentation
Technical documentation is the foundation of the conformity process. As per Annex II of the IVDR, it must include preclinical study results, performance evaluation data, software description, UDI details, and PMS procedures. It must also align with the post-market surveillance (PMS) plan.
Study Design and Regulatory Approval
The study design must define objectives, target population, inclusion/exclusion criteria, statistical methods, and risk analysis. Pure Clinical prepares complete documentation for ethics committees and national authorities, supporting study registration in EUDAMED.
Monitoring According to IVDR and GCP
IVD clinical studies are monitored in line with ISO 14155, ISO 20916, and GCP. Pure Clinical’s monitors oversee protocol compliance and data quality via pre-study, interim, and close-out audits.
Patient Safety Management
The vigilance system includes reporting of AEs, SAEs, and unexpected incidents under IVDR and local law. All events must be documented, classified, root-caused, and reported to authorities as required.
Statistical Analysis of Study Results
Statistical analysis is critical to evaluate device performance. The analysis plan defines populations (e.g., ITT, PP), predictive value calculations, significance thresholds, and methods for handling missing data. Data must be audit-ready and comply with ISO standards.
Final Study Report – CPSR
The Clinical Performance Study Report (CPSR) is a mandatory final report under ISO 20916. It includes performance analysis, clinical effectiveness, statistical summaries, monitoring records, and a lay summary as per Article 77 of the IVDR.
Data Management in IVD Studies
Data management systems (EDC, eCRF) must comply with ISO 15189, ISO 20916, and data integrity principles. Pure Clinical uses validated, auditable systems aligned with notified body expectations.
IVDR – Key Changes
IVDR 2017/746 replaces the former IVD Directive (98/79/EC), introducing new classification rules, mandatory performance evaluation, PRRC designation, expanded PMS duties, and a greater role for the notified body. The IVDR has been fully applicable since 26 May 2022. Non-compliance may result in market withdrawal.
How Pure Clinical Supports IVD Performance Studies
Pure Clinical supports manufacturers of in vitro diagnostic medical devices (IVDs) in planning, preparing, and conducting performance studies in accordance with applicable IVDR requirements and relevant principles of good clinical and research practice.
Depending on the product and project scope, support may include:
- Feasibility and classification assessment – assessment of study feasibility and IVD classification under the IVDR, including identification of the applicable regulatory pathway.
- Technical and performance documentation – preparation and review of documentation required to demonstrate the safety and performance of the IVD.
- Performance study planning and submission – preparation of study documentation and support with submissions to the relevant systems and authorities, according to the requirements applicable to the project.
- Study monitoring – support with study monitoring and applicable GCP requirements and standards relevant to the specific study.
- Data analysis and reporting – support with data analysis and preparation of the performance study report in accordance with applicable regulatory requirements.
- Integration with PMS and performance evaluation – integration of study results into performance evaluation documentation and, where applicable, post-market surveillance (PMS) processes.
Pure Clinical supports manufacturers in preparing IVD performance studies and related regulatory documentation, taking into account IVDR requirements, the characteristics of the IVD, and the objectives of the study.
FAQ
Can IVD study data collected before IVDR implementation be used in certification?
Must IVD studies be conducted exclusively in the EU to be recognized by notified bodies?
How often should IVD performance evaluation documentation be updated post-market?
The documentation should be updated periodically according to the PMS and PMPF plans. For Class C and D devices, updates are typically required annually or more frequently based on clinical risk. Each update must include post-market surveillance data, statistical analysis, and any protocol modifications.