With the transition to Regulation (EU) 2017/745 (MDR), the requirements for clinical trials for manufacturers of medical devices have also increased significantly. Clinical investigation is defined here as “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” (MDR, Article 2, 45).

But is clinical testing mandatory for manufacturers of medical devices? When does it make sense and what are the differences?

First of all: A clinical trial is not mandatory. However, it can be useful if, during the clinical evaluation, it becomes apparent that there are not enough clinical data available. Clinical data must then be collected per se when conducting a clinical trial in order to prove the promised benefit of the medical device. It is also important to check that the medical device is suitable for the intended purpose and that clinical safety and possible side effects have been considered.

The MDR is also clear here, as a basic requirement is that the clinical trial must ensure the following in its design and implementation with regard to the trial participants:

According to the MDR, clinical data are generated, among other things, from the clinical trial of the product in question and the clinical trial or other evidence that can be derived from comparable studies in scientific literature. Regulation (EU) 2017/745 defines clinical data as ” information concerning safety or performance that is generated from the use of a device” and which originate from the sources mentioned. (MDR, Article 2, 48).

Responsible for the oversight of the clinical trial is the sponsor—who must be established either themselves or through a legal representative in the Union—and a qualified investigator. In addition, the sponsor determines the appropriate monitoring and conduct of the clinical trial. Articles 62-80 of the MDR set out the requirements for clinical trials. DIN EN ISO 14155: 2021 sets out the procedure in even more detail to which manufacturers of medical devices must devote their attention.

Clinical trials are conducted in successive phases: from the definition of objectives, through trial planning and preparation, to the final evaluation and assessment of the data obtained.

All data recorded and collected during the trial must be stored by the sponsor or investigator in accordance with the applicable data protection regulations. Suitable technical and organizational measures should be taken in advance. In the event of emergencies in the participating groups of persons after the trial, the sponsor must define a plan for the immediate recall of the medical devices.