How to plan a clinical investigation of medical devices in Portugal
The high complexity and the advance in all areas of medicine and healthcare means that every day new technologies are created and tested to improve the health of individuals, including through clinical studies of medical devices1.
The sponsor is responsible for planning, conducting, and monitoring a clinical investigation of medical devices. It is essential in these steps to consider the most up-to-date scientific principles and knowledge, so that the results constitute sufficient evidence to demonstrate the good functional performance of the devices under normal conditions of use, according to its intended purpose.
Clinical investigations of medical devices should be performed by physicians or technicians with scientific qualifications and appropriate experience, particularly in clinical investigation and preferably in the area of the proposed research.
Good Clinical Practice procedures must also be followed, in accordance with EN ISO 14155 and relevant scientific guidelines issued by the European Commission.
The planning of a clinical investigation is usually framed within the context of the clinical evaluation of the medical device.
Clinical evaluation is a systematic and planned process to generate, collect, analyze, and evaluate clinical data regarding a device, with the aim of verifying its safety and performance, including clinical benefit, when used as intended by its manufacturer.
Generally, confirmation of compliance with general safety and performance requirements, as well as the assessment of undesirable side effects and the acceptability of the benefit-risk ratio, should be duly supported by a clinical evaluation based, as a general rule:
a. on a critical appraisal of the relevant scientific literature available;
b. on a critical appraisal of the results of all available clinical investigations, carried out in accordance with Articles 62 to 80 of the RDM;
c. on an analysis of alternative treatment options currently available for this purpose.
Clinical evaluation is a continuous process that does not end with the conformity assessment procedure. The clinical evaluation and its documentation are updated throughout the life cycle of the device in question through clinical data obtained from post-marketing clinical follow-up.
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1 For the purposes of Article 2 of Regulation (EU) 2017/745, a medical device is understood to mean any instrument, apparatus, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, in humans for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease;
- diagnosis, monitoring, treatment, alleviation or compensation of an injury or disability;
- study, replacement or alteration of the anatomy or of a physiological or pathological process or state;
- provision of information by means of in vitro examination of samples from the human body, including organ, blood and tissue donations.
and whose principal intended effect on the human body is not achieved by pharmacological, immunological or metabolic means, although its function may be supported by such means.
The following products are also considered medical devices: design control or support devices and products specifically intended for cleaning, disinfecting or sterilizing devices (i.e., medical devices, medical device accessories and the products listed in Annex XVI).
