Insights & Updates
Articles from the FirsTeckBio team on in-vitro diagnostics, IVDR regulation and the Italian market.
IVD and IVDR insights
- EN ISO 20916:2024 under IVDR: what harmonisation changes—and what it does not
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.
- Scientific Validity Reports under IVDR: from literature search to defensible evidence
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.
- The 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.
- IVD clinical performance studies under IVDR: practical do’s and don’ts
The fastest study is not the one with the shortest protocol. It is the one whose regulatory route, sample access, comparator, data model and decision rules are resolved before activation.