Research Roadmap

Performance studies using in-vitro diagnostics are subject to specific rules for submission, assessment and conduct. These rules are outlined in the EU In Vitro Diagnostics Regulation (EU No. 217/745, IVDR), which has been in effect since 26 May 2022.

What is an IVD?

The IVDR defines an in-vitro diagnostic medical device (IVD) as:

“Any medical device that is a reagent, a reactive product, a calibrator, a control material, a kit, an instrument, an apparatus, a device, software, or a system, whether used individually or in combination, and intended by the manufacturer to be used for the in-vitro examination of specimens derived from the human body, including donor blood and tissue, solely or principally for the purpose of providing information on one or more of the following:

• a physiological or pathological process or condition;
• congenital physical or mental impairments;
• the predisposition to a medical condition or a disease;
• determining the safety and compatibility with potential recipients;
• predicting the response or reactions to treatment;
• determining or monitoring therapeutic measures.

Specimen receptacles are also considered medical devices for in-vitro diagnostics.”

For more information, see the MDCG guidance document.

Categories of IVD performance studies

A performance study is “a study conducted to determine or confirm the analytical or clinical performance of a device”. Analytical performance refers to the ability of an IVD to accurately detect or measure a specific analyte. Clinical performance refers to the ability to provide clinically relevant results.

The IVDR distinguishes different types of performance studies, each with specific requirements and procedures:

1. Performance studies involving risks to subjects (IVDR Article 58.1 and Article (70.2);

   • in which the surgically invasive sampling is carried out solely for the purpose of the performance study; or
   • which is an interventional clinical performance study in which the test results may influence patient care decisions and/or be used to guide treatment; or
   • in which the conduct of the study involves additional invasive procedures or other risks to the subjects of the studies.
2. Performance studies with companion diagnostics (CDx) (IVDR Article 58.2);
3. Post-market performance follow-up (PMPF) studies with additional invasive and/or burdensome procedures (IVDR article 70.1);
4. Performance studies without risks to subjects (IVDR article 57).

Consult the CCMO website for more information on these categories and a flowchart to determine which framework applies to your performance study.

Development of diagnostic laboratory tests in Amsterdam UMC

Under the IVDR, diagnostic laboratories are required to add a justification statement to the validation report. In addition, they must prepare and publish a statement on the use of in-house IVDs for users. Please consult Amsterdam UMC's general topic page on IVDs to learn more about the necessary steps.