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An organisation designated by an EU member state to assess the conformity of products — including in vitro diagnostics — against applicable regulations before CE marking can be affixed.

Regulatory Definitions

Article

Oral wash PCR for the diagnosis of Pneumocystis jirovecii pneumonia in non-HIV immunocompromised hosts: a diagnostic accuracy study.

Research record from Med Mycol, 2026-08-01. PMID 42593422.

Article

Organ-on-a-chip platforms for disease modeling and in vitro diagnostic applications.

Research record from Front Bioeng Biotechnol, 2026-09-17. PMID 42824806.

Article

Oropharyngeal Treponema pallidum DNA Detection in Early Syphilis: Diagnostic Yield of Pharyngeal PCR and Potential Implications for Mucosal Shedding.

Research record from Int J Dermatol, 2026-07-18. PMID 42470253.

Article

Outbreak-ready: validation and regulatory groundwork to prepare before the next PHEIC

Prepare for the next public-health emergency now: validation groundwork, WHO EUL familiarity, platform flexibility, and the documentation emergency reviewers will ask for.

Article

Overcoming Clinical Validation Challenges for an In Vitro Diagnostic Biodosimetry Test.

Research record from Mil Med, 2026-08-01. PMID 42560237.

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