Performance studies (IVDR)
IVDR Art. 57–77 and Annex XIV. Performance studies are studies conducted on specimens from human subjects specifically to evaluate the performance of an IVD. They have their own regulatory framework distinct from MDR clinical investigations.
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
What is a performance study?
A performance study is any investigation involving the collection and use of specimens from subjects to evaluate the analytical or clinical performance of an IVD. This distinguishes performance studies from:
- Pure laboratory studies using reference materials or previously collected specimens without a study protocol
- Post-market surveillance data collection (not a structured performance study)
Performance studies are the primary mechanism for generating clinical performance data — especially diagnostic sensitivity and specificity — in the intended patient population.
Types of performance studies
Interventional performance studies (Art. 58)
A study is interventional if it involves one or more of:
- Additional invasive procedures beyond standard of care
- Additional radiation exposure
- Additional blood sampling not part of routine care
- Changes to standard treatment protocols
Interventional studies require the highest level of regulatory oversight.
Non-interventional performance studies (Art. 58(2))
A study is non-interventional if specimens are collected solely as part of standard care and the study procedure imposes no additional risk or burden on subjects. Most retrospective studies using archived specimens fall here.
Non-interventional studies still require ethics committee oversight but have lighter NCA notification requirements.
Regulatory requirements by study type
| Requirement | Interventional | Non-interventional |
|---|---|---|
| EUDAMED registration | Yes | Yes |
| Ethics committee approval | Yes | Yes (in most member states) |
| NCA authorisation | Yes (30-day review window) | Notification only (in most cases) |
| Informed consent | Yes — full written consent | Depends on specimen provenance; may be waived for anonymised archived samples |
| Sponsor responsibilities | Full (per Annex XIV) | Lighter |
Sponsor responsibilities
The sponsor of a performance study (typically the manufacturer or an entity they appoint) is responsible for:
- Designing the study (performance study plan — equivalent to CIP in clinical investigations)
- Obtaining ethics committee and NCA approvals/notifications
- Registering in EUDAMED
- Ensuring investigator site qualifications
- Monitoring the study
- Reporting serious adverse events to NCAs
- Preparing the performance study report
Performance study plan
The study plan must include:
- Objectives and hypotheses
- Study design and rationale
- Subject population and specimen criteria
- IVD and comparator/reference method description
- Primary and secondary performance parameters
- Sample size justification
- Statistical analysis plan
- Adverse event definitions and reporting
Performance study report
On completion, a full report documenting all study conduct, data, analyses, and conclusions must be prepared and included in the technical documentation.
Related pages
- Performance evaluation
- Clinical investigations (MDR)
- Using international clinical data
- Companion diagnostics
Official references
| Reference | Description |
|---|---|
| IVDR Art. 57–77 | Performance study framework |
| IVDR Annex XIV | Performance study requirements |
| MDCG 2022-9 | Performance evaluation guidance |