IVD & Molecular Diagnostics Glossary

A manufacturer declaration that an in vitro diagnostic complies with applicable EU legislation (the IVDR since May 2022). CE-IVD indicates regulatory conformance, not a statement of clinical superiority; buyers still review performance claims and intended use.

A WHO procedure that time-limits the listing of diagnostics (and other health products) for use in public-health emergencies when full prequalification is not yet available.

A US pathway in which a device maker demonstrates substantial equivalence to a legally marketed predicate. For IVD test kits, 510(k) clearance documents intended use and analytical/clinical support; it is distinct from CLIA waiver, which concerns point-of-care operation settings.

EU Regulation 2017/746 governing in vitro diagnostics, which replaced the IVDD with stricter evidence, post-market surveillance, and reclassification rules. Products legacy-listed under the IVDD may still carry transitional timelines, so registration status should be verified per product and per market.

The international quality-management standard for medical device manufacturing. Certification does not certify individual products, but suppliers with ISO 13485-registered production generally support tender documentation more reliably.

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.

A WHO assessment that confirms a diagnostic meets quality, safety, and performance requirements for procurement by UN agencies and many national programs. WHO PQ status is frequently a tender eligibility criterion for public-health deployment in low- and middle-income countries.