Orphan IVD

MDCG 2026-6 brings the orphan approach to IVDs, so the performance evidence at certification can reflect how few cases can be tested. The test must also lack sufficient alternatives or offer an expected clinical benefit over them.

For the purpose of this guidance, an IVD is regarded as ‘orphan IVD’ if it meets the following criteria: - the IVD is specifically intended to test persons for a disease/condition or in circumstances that present in not more than 12,000 individuals in the European Union per year, AND at least one of the following criteria are met: • there are insufficient available alternatives, or • the IVD will provide an expected clinical benefit compared to available alternatives or state of the art.

MDCG 2026-6, Section 4.1, Orphan IVD criteria