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An IVD performance study route depends on how specimens and results are used, not only on whether a laboratory is involved.
IVDR performance studies — Define the regulatory scope
IVDR Articles 57, 58 and 70 distinguish performance study situations. MDCG 2025-5 provides practical questions on applicability, including particular study designs.
IVDR performance studies — Build the working record
Prepare a route worksheet covering specimen collection, additional invasive procedures, interventional use, risks, CE status and intended purpose. Include companion diagnostic considerations where relevant and determine country procedures before recruitment or sample collection.
IVDR performance studies — Check before release
- Describe whether results influence patient management.
- Separate leftover from prospectively collected specimens.
- Check additional risks and participant consent requirements.
IVDR performance studies — Record the decision and handover
Approve the classification with clinical, laboratory and regulatory owners. Keep medicinal product trial and IVD requirements in separate linked workstreams when both apply; one authorisation does not automatically cover the other.
Frequently asked questions
- Are leftover specimens always outside IVDR study rules?
- No. Assess the specific design and applicable provisions rather than assuming an exemption.
- Does a drug trial approval cover its investigational test?
- No. Evaluate the IVD and any performance study obligations separately.