Clinical investigations of medical devices – when and how you should carry them out according to MDR
With the transition to Regulation (EU) 2017/745 (MDR), the requirements for clinical investigations for manufacturers of medical devices have also increased significantly. Clinical investigation is defined here as “a systematic investigation involving one or more human subjects and conducted for the purpose of evaluating the safety or performance of a device” (MDR, Article 2, 45).
But is clinical investigation mandatory for manufacturers of medical devices? When does it make sense and what are the differences?
Firstly: A clinical investigations is not mandatory. However, it can be useful if it becomes apparent during the clinical evaluation that not enough clinical data is available. In this case, clinical data must be collected by conducting a clinical trial per se in order to prove the promised benefit of the medical device. In addition, it must be verified that the medical device is suitable according to its intended purpose and that clinical safety and possible side effects have been considered.
What should you pay attention to during the clinical investigations?
The MDR also becomes 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:
These requirements must be given priority in every clinical investigations. Furthermore, Article 62 of the EU Regulation requires scientifically sound, reliable and robust data as the results of the trial.
What is clinical data?
According to the MDR, clinical data is generated, among other things, from the clinical investigation of the device in question and the clinical investigation or other evidence that can be derived from comparable studies in scientific literature. Regulation (EU) 2017/745 defines clinical data as “information on safety or performance obtained in the course of the use of a device” and which originates from the sources mentioned. (MDR, Article 2, 48).
Conducting the clinical investigation
The sponsor – must be established in the Union itself or through a legal representative – and a qualified investigator are responsible for the supervision of the clinical investigation. The sponsor also determines the appropriate monitoring and conduct of the clinical trial. Articles 62-80 of the MDR set out the requirements for clinical investigation. DIN EN ISO 14155: 2021 sets out the procedure in even more detail, to which manufacturers of medical devices must devote their attention.
Clinical investigation are carried out 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 investigation must be stored by the sponsor or investigator in accordance with the applicable data protection regulations. Suitable technical and organisational measures should be taken in advance. In the event of emergencies involving the participating groups of people after the trial, the sponsor must define a plan for the immediate recall of the medical devices.
Are there differences?
While previously the focus was on regular clinical investigations, which serve to analyse the benefit-risk of the medical device, for example, there are other clinical investigations under the MDR. These collect results for basic research and feasibility studies, for example. Requirements and limitations can be found in Article 62 of (EU) 2017/745.