Building an IVDR performance evaluation plan: from claims to evidence
A useful PEP makes the next evidence decision clear: what must be demonstrated, what already supports it and which work is still needed.
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IVD insights & regulatory updates
Practical guides for laboratory teams and IVD manufacturers: diagnostic workflows, study planning and IVDR evidence.
7 results
Choosing IVD study sites: a practical feasibility review
A site’s total testing volume is not its study recruitment capacity. Evaluate the complete path from eligible specimen to usable result.
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Selecting a diagnostic analyser for the laboratory workflow
The right comparison starts with the work your laboratory needs to complete: samples, reporting times, operators and continuity of service.
Read articleEN ISO 20916:2024: applying the harmonised standard under IVDR
Harmonisation can support a presumption of conformity for the requirements it covers. It does not replace the intended-purpose rationale, performance-evaluation plan or study-specific scientific judgement.
Read articleWriting an IVDR Scientific Validity Report
A literature search is only the retrieval method. Scientific validity is the reasoned link between an analyte or marker and the clinical condition or physiological state named in the intended purpose.
Read articleThe IVDR companion diagnostic consultation path: notified body, EMA and timing
For a companion diagnostic, the notified body remains responsible for conformity assessment, but it must seek a scientific opinion from the relevant medicines authority before issuing the certificate.
Read articlePlanning an IVDR clinical performance study
Before activating sites, confirm the regulatory route, specimen access, comparator, data model and analysis rules. These decisions shape the feasibility and quality of the study.
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