The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) sets much stricter and more detailed requirements for the performance evaluation of IVDs. This article explains the core content of the performance evaluation plan to help manufacturers move their registration forward.
1. The performance evaluation plan
Under Annex XIII, Part A, Section 1.1 IVDR, the performance evaluation plan must include in particular:
- the intended purpose of the device;
- the characteristics of the device as described in Annex I, Chapter II, Section 9 and Chapter III, Section 20.4.1(c);
- the analyte or marker to be determined;
- the identification of certified reference materials or reference measurement procedures to allow metrological traceability;
- a clear specification of the intended patient groups with clear indications, limitations and contraindications;
- the general safety and performance requirements (Annex I, Sections 1 to 9) that require support from relevant scientific validity, analytical and clinical performance data;
- the methods, including appropriate statistical tools, used to examine the analytical and clinical performance and the limitations of the device and the information it provides;
- a description of the state of the art, including relevant standards, common specifications (CS), guidance or best-practice documents;
- parameters to determine the acceptability of the benefit-risk ratio based on the state of the art in medicine;
- for software qualified as a device, the identification of reference databases and other data sources used for decision making;
- an outline of the development phases, including the sequence and means of determining scientific validity, analytical and clinical performance, with milestones and acceptance criteria;
- post-market performance follow-up (PMPF) planning.
In practice, the plan can be organised into the following modules:
| Module | Content |
|---|---|
| 1. Device description | Intended purpose, classification rationale (class A/B/C/D), target patient population, contraindications and limitations |
| 2. Performance characteristics | Analyte/marker definition, reference standards, measuring range, stability (e.g. specimen storage conditions, reagent shelf life) |
| 3. Evaluation methods | Data sources (literature, clinical studies, laboratory data), statistical methods, acceptance criteria (e.g. sensitivity ≥ 95%) |
| 4. State of the art | Reference standards (e.g. ISO standards, common specifications), peer-reviewed literature, comparison with similar devices |
| 5. Risk management integration | Risks arising from performance deficiencies (e.g. false-positive results delaying treatment), linked to risk management files such as the DFMEA |
| 6. Post-market follow-up | PMPF strategy and update frequency (for class C and D devices, the performance evaluation report is updated as required, at least annually) |
2. Demonstrating scientific validity and performance
Under the IVDR, manufacturers must demonstrate the scientific validity, analytical performance and clinical performance of the device:
- Data collection and gap identification: collect all data relevant to the device and its intended purpose, usually through a systematic literature review, and identify open questions or gaps; evaluate safety and performance by integrating all relevant data and generate new or additional data where needed.
- Scientific validity: can be demonstrated using one or more sources – information on devices measuring the same analyte or marker, peer-reviewed literature, consensus expert opinions or positions of professional associations, results of proof-of-concept studies and results of clinical performance studies. The scientific validity report documents this.
- Analytical performance: unless a deviation is duly justified, demonstrate all parameters described in Annex I, Section 9.1(a).
- Clinical performance: likewise, unless duly justified as not applicable, demonstrate all parameters in Annex I, Section 9.1(b).
3. Clinical evidence and the performance evaluation report
- Assessment: the manufacturer must assess all relevant scientific validity, analytical and clinical performance data to verify conformity with the general safety and performance requirements.
- Report and updates: the clinical evidence is documented in the performance evaluation report, which includes the scientific validity report, the analytical performance report, the clinical performance report and an assessment of these reports. For devices with a PMPF plan as part of the post-market surveillance system under Article 10(9), the clinical evidence and its assessment must be updated throughout the lifecycle. The performance evaluation report is a key part of the technical documentation.
4. Common challenges and solutions
| Challenge | Solution |
|---|---|
| Insufficient data | Use existing data, e.g. analytical performance reports from an FDA 510(k), and close the gaps identified in a gap analysis |
| Notified body review delays | Engage a notified body early and plan sufficient time and budget |
| Broad intended purpose | Narrow the claims (e.g. “for adults only”) and support the biomarker’s general validity (e.g. the association of CRP with inflammation) |
| Transition of legacy devices | Use existing data in line with MDCG 2022-2, supplemented with IVDR-specific elements such as PMPF |
Note: ensure data reliability by not relying on a single source (such as literature only) – combine laboratory and clinical data. And link risk management directly: map each performance limitation to a risk control measure, such as clearer instructions for use to reduce misuse.
How EVERBIZ can help
EVERBIZ draws on extensive practical experience in quality systems and product registration. For case studies or help completing performance evaluation templates, contact us.
This article is for general information only and does not constitute legal advice.