What requirements must investigational medical devices meet?15-09-2017
However, the regulations on clinical trials in Spain and Europe apply both to drugs and medical devices. Likewise, just as we must request the classification as an Investigational Medicinal Product (IMP) to be able to use a drug in clinical research, we must also have the authorization of thee AEMPS to conduct a clinical trial with a medical device.
As a general rule, all medical devices must be labeled with the CE brand, but there are exceptions: customized medical devices and those intended for clinical research.
It can also happen that the medical device used in the clinical trial has the CE brand but the aim of the research is to show its usefulness for a different purpose or in different conditions than those indicated by the manufacturer.
In both cases, a clinical and pre-clinical plan must be designed based on the inherent risks of devices, taking into account the duration of contact with patients, the device's invasiveness, the condition to treat or diagnose, etc.
Prior to starting a clinical research, the study must have the favorable judgment of the AEMPS and the EC selected by the sponsor (which in this case does not have to be an accreditedREC for the assessment of clinical trials with drugs, i.e., the MREC), as well as the approval of the directors of the site where it will be conducted.
During the clinical trial, the performance of the product will be verified, and any potential side effects will be identified which, in case of being serious, must be immediately recorded and reported to the competent authorities.
The physician or person responsible for testing the medical devices will have access to all the technical and clinical data associated with them and, once the research has been completed, he/she will draft and sign a written report, including a critical evaluation of the data obtained during the research.
The manufacturer's responsibilities do not end upon completion of the clinical trial, since the Declaration of Conformity and the Report with the conclusions of the research must remain available to the competent authorities for a period of five years, and of 15 years in the case of implantable products.
At BioClever, all our experience in health product research, from study design and implementation to the results report and scientific disclosure is made available to investigators, public entities and industries.
And, if you still have doubts, you can contact us for any further information and references you may need.
Labels: Investigational product, clinical research, CE brand, medical devices