The role of manufacturers in the devicevigilance
Medical devices (MDs) are a category including a wide range of products whose use by consumers in everyday life is more and more increasing.
In compliance with the current Italian regulations, a medical device is
“any instrument, apparatus, appliance, software, material or other product to be used alone or in combination, including the software intended by the manufacturer to be used for specific diagnostic or therapeutic purposes, and needed for the correct functioning of the device, intended by the manufacturer to be used in humans for the purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability; investigation, replacement or modification of the anatomy or of a physiological or pathological process; intervention on conception, which product does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”
It is therefore clear that products with extremely different and varied intended uses are all classified as medical devices.
Actually, there are medical devices that can be purchased and used independently by consumers (such as patches or thermometers to measure body temperature) and others that require qualifications and training and that can therefore be used only by a competent doctor (such as pacemakers or prostheses). Although the intended uses can be so different, the obligation for the manufacturer and the responsible person for the product are the same for all medical devices.
Of course, the manufacturer shall ensure that the marketed products are safe and compliant with the regulations. However, adverse events can happen following the use of the product, or it could happen that a quality defect or a non compliance arise only after a certain batch of the product has been put on the market.
In all these cases, the manufacturer of the MD shall act promptly in order to prevent or limit any safety problem related to the use of the product. The manufacturer has therefore an active role also in the post-marketing phase.
The regulations, in fact, establish the obligations of the manufacturers or their authorised representatives regarding the vigilance on the incidents with medical devices, in particular the immediate communication of all incidents they have become aware of to the competent authorities, and all the corrective actions that have been taken to prevent or reduce any risk of death or severe health worsening associated to the use of a device.
Moreover, the manufacturer is also responsible of the management of other inconveniencies without the features required to consider them as actual incidents, but still requiring corrective actions.
The manufacturers shall also carry out a surveillance to research and investigate any reports on medical devices similar to their own.
Managing the devicevigilance and devicesurveillance is therefore a complex activity that should be performed in compliance with the regulations. For these reasons, more and more manufacturers prefer to entrust consultancy companies with this kind of activity. Consultants are able to ensure that all activities are carried out regularly as well as in compliance with the legal requirements.
Written by: Federica Montozzi
