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 Clinical Investigations

Pure Clinical provides end-to-end support to IVD manufacturers, including:

  • Feasibility and classification analysis per IVDR,
  • Preparation of technical and clinical documentation,
  • Study planning and registration with EUDAMED and national authorities,
  • GCP- and ISO 14155-compliant monitoring,
  • Statistical analysis and CPSR development,
  • Data integration into PMS and performance evaluation files.

Our expertise streamlines implementation, prevents regulatory errors, and supports successful notified body assessments.

FAQ

Can IVD study data collected before IVDR implementation be used in certification?

Yes, but only if it meets the minimum quality and documentation standards outlined in IVDR. A retrospective compliance evaluation with GCP, ISO 14155, or ISO 20916 is required. The data must also be interpreted in light of current clinical risk and may need to be supplemented by PMS analysis or additional studies confirming performance.

Must IVD studies be conducted exclusively in the EU to be recognized by notified bodies?

No – studies can be conducted outside the EU, but they must adhere to GCP, ISO 20916, and local regulations offering an equivalent level of participant protection as required by IVDR. Auditability, source data accessibility, and consistency with clinical documentation are essential for acceptance.

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.

Does reclassification of an IVD during a study affect the sponsor’s regulatory obligations?

Yes – if a product is reclassified (e.g., from Class B to C) due to regulatory reinterpretation or methodological changes, the sponsor must promptly adjust the study scope, update EUDAMED records, and inform the notified body. This may also require re-approval from the ethics committee.