Regulatory affairs medical devices registration consulting services Poland

We offer you authorization (registration) of medical devices in Poland according to medical device class and type as well as preparation of proper labelling according to Polish law and medical devices consulting. We can also help you with getting CE mark from notified bodies.

Medical devices are classified on the basis of composition, construction and method of use into several categories: active implantable medical devices, in vitro diagnostic medical devices and general purpose medical devices. Conformity assessment of medical device, necessity of assessment by notified body as well as medical device autorization (registration) process depend on type and class of the device.