What is a clinical investigation?

‍A clinical investigation is a study to evaluate the safety or performance of a medical device for which there is a study plan or study protocol that precisely defines all the steps in advance (prospectively). A clinical investigation can be conducted with very few participants or with hundreds to thousands of participants, either in a single country or internationally.

Classification of terms based on standards and laws

The terms clinical investigation, clinical study, clinical investigation after placing on the market or other clinical investigation are terms from Regulation (EU) 2017/745 (MDR) or the German version of EN ISO 14155:2020 or EN ISO 14155:2021-05 and the Medizinprodukterecht-Durchführungsgesetz in Germany. For in-vitro diagnostics, which are also medical devices, the term performance study from Regulation (EU) 2017/746 (IVDR) is used.

Use of the terms clinical investigation or clinical study

Scientific studies to prove the medical benefit or other positive healthcare effects of Digital Health Applications (DiGA), which are also medical devices, are regulated by the Digital Health Applications Ordinance (DiGAV), the DiGA guidelines of the Federal Institute for Drugs and Medical Devices (BfArM) and the Act to Accelerate the Digitalisation of the Healthcare System (Digital Act, DigiG). In these legal texts and guidelines, the term "clinical studies" is consistently used synonymously with "clinical investigations" (see ISO14155, 3.8).

In EN ISO 14155:2020, as well as in everyday language, the terms "clinical study" and "clinical investigation" are used synonymously with "clinical trial".

A distinction is made between the following phases in a clinical investigation: design, planning and set-up, implementation with follow-up, data management, evaluation and interpretation, and publication.

Even if these phases are always necessary, the respective design depends on the respective legal provisions (regulations), the product, the participants, the risk of the product or the study, the interest of the sponsor (responsible party, usually the manufacturer), the number of digital study elements, the purpose of the clinical investigation, the positioning of the product (marketing) or the unmet medical need.

(as of spring 2024)

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