Performance evaluation is central to demonstrating conformity under the EU IVDR. To date manufacturers have typically established their performance evaluation frameworks by drawing on the Regulation, MDCG guidance and several standards addressing individual parts of the evidence lifecycle.
A new ISO project, currently under development, may eventually provide a more consolidated international reference for performance evaluation framworks.
ISO/CD 26358, In vitro diagnostic medical devices—Performance evaluation—Requirements and guidance, has now reached the Committee Draft stage. According to its published scope, the future standard is intended to address how evidence is planned, generated, appraised, analysed and reported to demonstrate the following performance pillars:
- scientific validity;
- analytical performance; and
- clinical performance.
Importantly, the intended scope covers both pre-market and post-market phases.
Why the proposed standard matters
Under Article 56 and Annex XIII of the IVDR, an IVD manufacturer must plan, conduct and document performance evaluation throughout the device lifecycle. The three performance pillars cannot be treated as unrelated reports: together, they must support the intended purpose and demonstrate that the device achieves its claimed performance and clinical benefit.
In practice however, manufacturers often encounter difficulties such as:
- poorly defined links between intended purpose, claims and evidence;
- overlap or gaps between analytical and clinical performance activities;
- literature searches that are not clearly connected to specific evidence questions;
- legacy evidence that has not been critically appraised;
- performance evaluation reports that summarise data without reaching transparent conclusions; and
- post-market information that does not meaningfully update the original evaluation.
Based on the published project scope, ISO/CD 26358 appears intended to provide a structured framework spanning this entire process. If retained in the final standard, this lifecycle perspective could help manufacturers move from a collection of separate documents towards a genuinely integrated evidence system.
What should IVD manufacturers do now
It would be premature to revise procedures to comply with a Committee Draft. The document may change substantially before publication.
Nevertheless, its scope provides a useful prompt for reviewing existing practices.
Check the evidence chain
Start with the intended purpose and performance claims. Can each claim be traced to appropriate scientific-validity, analytical-performance and clinical-performance evidence?
The connection should be visible without relying on undocumented knowledge held by individual specialists.
Review the performance-evaluation plan
Confirm that the plan defines:
- the questions the evaluation must answer;
- the types and sources of evidence required;
- scientifically justified acceptance criteria;
- methods for identifying and appraising existing data;
- remaining evidence gaps; and
- how post-market information will update the evaluation.
Note that a plan written after completion of performancestudies is unlikely to function as a meaningful evidence strategy.
Examine interfaces between disciplines
Performance evaluation frequently involves regulatory, clinical, laboratory, statistical, risk-management and post-market expertise. Review whether responsibilities and handovers between these functions are clearly defined.
Many evidence gaps arise at the interfaces, for example, when an analytical limitation is identified but its effect on clinical performance, residual risk or user information is not assessed.
Connect post-market activities to the original claims
Post-market performance follow-up should not operate as a separate exercise. Its outputs should feed back into the performance-evaluation report, risk-management documentation and, where necessary, the intended purpose, claims or instructions for use.
Monitor the standard’s development
Organisations with relevant expertise may wish to follow the work through their national standards body. Others should at least monitor the project as it progresses from Committee Draft towards Draft International Standard and final publication.
Conclusion
ISO/CD 26358 remains a developing ISO project and should not be regarded as a published standard or additional regulatory requirement. Its development is nevertheless significant because it addresses an area where many IVD organisations need greater structure: managing scientific validity, analytical performance and clinical performance as one coherent lifecycle process.
At this stage, the most appropriate response is not immediate procedural change, but rather a critical review of the current performance-evaluation process. Organisations should consider if their performance evaluation system provides clear traceability from intended purpose and claims to evidence generation, evaluation conclusions, risks management and post-market activities.
Organisations that already manage these connections effectively will be better placed to assess and, where appropriate, adopt the future standard once its content has stabilised.
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