Obligations of importers and distributors
For obvious reasons, the Act of 20 May 2010 on Medical Devices (Journal of Medical Devices) U. of 17 June 2010, as amended. (zm.) imposes…
Supervision of medical devices
In view of the need to protect public health and to address the risks that may arise from the use of a medical device, and…
Clinical trials of medical devices
As in the case of medicinal products, special testing programmes are carried out on a specific group of persons in order to check and confirm…
Inclusion of product group 1 by notification
It is useful to know that in certain situations a mandatory notification or notification concerning, in principle, the placing on the market of a medical…
Medical device
a tool, instrument, device, software, material or other article, whether used alone or in combination, including software intended by its manufacturer for use specifically for…
Classification rules
are based on the sensitivity of the human body, taking into account the potential risks associated with the technical design and manufacture of such devices),…
In vitro diagnostic medical device
this is: (a) a medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or…
Active implantable medical devices
constituting medical devices, including any equipment the functioning of which depends on an energy source other than energy generated directly by the human body or…
Medical device equipment
an article which, without being a medical device, is specifically intended by the manufacturer for use together with a medical device in order to enable…
Eudamed
Eudamed is a European database on medical devices, which was established at the level of European Union legislation by commission decision of 19 April 2010….