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Productos sanitarios en investigación, ¿qué requisitos deben cumplir?

In this definition, those products "that exercise their main action by pharmacological, immunological or metabolic means" are excluded, since, in this case, they would be considered drugs and, therefore, their authorization procedure would be different. 

However, the regulation that regulates clinical trials in Spain and Europe, is applicable to both medicines and medical devices. And just as we must request the qualification as a Research Product (PEI) to be able to use a medicine in clinical research, we must also have authorization from the AEMPS to carry out clinical trials with a medical device. 

The general rule indicates that all medical devices must have the CE mark on their labeling, but there are two situations in which they may exceptionally not have it: customized medical devices, and those intended for clinical research.  

It can also happen that the sanitary product used in the clinical trial does have CE Marking, but that the objective of the research is to demonstrate its usefulness for a different purpose or under conditions different from those indicated by the manufacturer.  

In both cases, a preclinical and clinical development plan must be designed according to the risks inherent to the product, taking into account the duration of contact with the patient, the invasiveness of the product, the pathology to be treated or diagnosed, etc. 

Before beginning the clinical investigation, the study must have the favorable opinion of the AEMPS and the CEI selected by the promoter (which in this case will not have to be an accredited IEC for evaluation of clinical trials with drugs, CEIm), as well as the conformity of the address of the center where it will be carried out.  

During the clinical trials the operation of the product will be verified and possible side effects will be determined which, in the case of being serious, must be registered and immediately communicated to the competent authorities. 

The doctor or the person responsible for the tests with medical devices will have access to all the technical and clinical data related to the product, and once the investigation is finished, it will prepare and sign a written report,<a href="http://www.replicasrelojes.info">replicas relojes</a> including a critical evaluation of the data obtained during the investigation. .  

The responsibilities of the manufacturer will not end at the end of the clinical trial, since the Declaration of Conformity and the Report with the conclusions of the investigation should remain available to the competent authorities for a period of 5 years, which will be 15 in the case of implantable products. . 

At BioClever we make available to researchers, public entities and industry all our experience in research with health products, from the design and implementation of studies to the report of results and its scientific dissemination.  

And if you still have doubts, contact us and ask for any additional information you want as well as references.  

Tags:  Product in Research, clinical research, CE marking, medical devices, medical devices
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