Badania kliniczne wyrobów medycznych
Podobnie jak w przypadku produktów leczniczych, aby sprawdzić i potwierdzić skuteczność oraz bezpieczeństwo działania wyrobu medycznego na ludzki organizm, przeprowadza się specjalne programy badań na…
ARTYKUŁY
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….