Regulatory Notice

In vitro diagnostics are regulated products. This notice explains how regulatory information is presented on IVDmap and what it does not represent.

Regulatory status of listed products

Products listed on IVDmap may carry regulatory markings such as CE under the EU In Vitro Diagnostic Regulation (IVDR), FDA 510(k) clearance, or national registrations. Where shown, such statuses are compiled from public sources and may lag behind official records; they may also refer to a specific intended purpose or specimen type, which should be matched against your own intended use. The authoritative source for any product’s regulatory status is always the relevant authority’s own database — for example EUDAMED or the FDA 510(k) database — together with the manufacturer’s declaration of conformity and instructions for use.

IVDmap is not a regulatory body

IVDmap is not a notified body, regulator, registrar, or certification agent. Displaying a product or a regulatory claim on the platform is not an approval, verification, or endorsement. Catalog entries are informational and carry no regulatory effect.

Regional variation

Regulatory requirements for IVD products differ by jurisdiction and change over time. The EU is transitioning from the IVDD to the IVDR, with legacy certificates expiring on defined timetables and many products requiring new conformity assessments. The United States, China, Japan, and other markets each maintain distinct registration, import, and labeling regimes. A product lawfully placed on one market may not be lawfully placed on another, so procurement teams should plan requalification ahead of certificate expiry dates.

Professional procurement responsibility

Buyers are responsible for verifying that each product they procure complies with the requirements of their jurisdiction and intended use, including registration status, labeling language, storage conditions, and any national tender or import conditions. Where needed, request current certificates and regulatory documentation from the manufacturer or distributor before committing to a purchase. Distributors should similarly confirm the scope of their authorization.

Contact

Questions about the regulatory information shown for a specific product can be sent to [email protected] or raised with the supplier through an RFQ. Regulatory positions summarized on product pages are reviewed periodically, but timeliness cannot be guaranteed. We correct catalog entries when reliable sources are provided.

Last updated: 3 October 2026.