The Role of Biobanking in IVD Performance Evaluation under IVDR
Performance evaluation of a diagnostic device is not a one-time activity but a continuous process throughout the product lifecycle. Manufacturers must demonstrate the scientific validity of the test, as well as its analytical and clinical performance, and continuously update conclusions in response to changes in patient populations, clinical practice, and epidemiological circumstances.
Biobanking of samples allows manufacturers to shorten study timelines by eliminating the need for lengthy patient recruitment. From the outset, it is critical that biobanking processes ensure full traceability of samples, quality control, and informed patient consent for the use of their biological material in future performance evaluations.
Another important aspect is the regular replenishment of biobanks with samples from successive disease seasons. This allows verification of device performance in changing populations and against new pathogen variants, ensuring that the evidence remains current and reliable as required under IVDR.
Samples as Evidence: IVDR Requirements
According to IVDR, the result of a diagnostic test constitutes evidence of its performance. To ensure reliability, every sample used in performance evaluation must have a fully documented history—from collection, preparation, and transport to storage. All these processes must be conducted in a manner that does not compromise future test results, while remaining transparent, controlled, and audit-ready.
Meeting these requirements ensures that samples are of high quality and fully suitable for IVD performance evaluation studies.
Two Models of Sample Acquisition for IVD Performance Evaluation
Left-over Samples
This approach involves collecting samples remaining from routine diagnostics, which can later be used in performance evaluation studies. No additional material beyond that required by the diagnostic protocol is collected from participants. A key limitation is often the small volume of available material, which may be insufficient for studies requiring larger sample quantities.
Dedicated Biobank Samples
In this model, biological material is specifically collected for biobanking purposes. Participants may still receive diagnostic test results, but additional material is collected solely for future performance evaluation. Typically, larger sample volumes are collected compared to left-over samples, increasing their research value and enabling diverse analyses within the framework of evaluating a specific IVD device.
Key Considerations for Sponsors Selecting Biobank Samples
Using samples from a repository allows sponsors to shorten study timelines and reduce costs, as it avoids full patient recruitment and lengthy material collection. However, mere availability of samples does not guarantee their suitability for use in studies. It is crucial that biological material meets defined quality and legal requirements. Regardless of the acquisition model, sample use in IVD performance evaluation requires adherence to several key criteria:
- Patient consent – confirmed permission for the biological material to be used in performance evaluation studies.
- Data protection compliance – storage and use of associated data must comply with GDPR and local regulations.
- Data quality and completeness – samples must be properly documented, and associated data (e.g., clinical information, collection, transport, and storage conditions) must be complete and reliable.
Only samples meeting these criteria constitute a robust and reproducible evidence base, enabling sponsors to obtain reliable clinical evidence for the performance evaluation of the IVD device.
Summary
IVDR requires that the performance of diagnostic devices be assessed throughout the entire product lifecycle. Access to materials stored in biobanks enables manufacturers to conduct studies more quickly, at relatively lower costs, and with an almost negligible risk of delays in study execution.
A process-driven approach to biobanking is crucial, ensuring full traceability of samples, effective quality control, and a clearly defined legal basis for their use. Planned biobanking — including both left-over samples from routine diagnostics and samples collected specifically for the biobank (dedicated biobank samples) — allows control over documentation, sample types, the scope of clinical data, and quality criteria, minimizing the risk of data gaps and inconsistencies.
Regular replenishment of biobanks with samples from successive disease seasons allows verification of device performance in a changing population and against new pathogen variants, ensuring the durability and reliability of the evidence required under IVDR.
Sources
- Regulation (EU) 2017/746 (IVDR), PDF (EUR-Lex): link
- MDCG 2025-5, PDF (European Commission): link
- MDCG 2025-10, PDF (European Commission): link
- ISO 20387:2018 — Biotechnology — Biobanking (ISO): link