With regard to notifications and submissions covering all medical devices, we carry out a specialised assessment of the documentation provided, on the basis of which we assist in obtaining a CE Certificate of Conformity from the Notified Body appropriate for the specific medical products. We prepare the documentation necessary for submission to the Registration Office.
Medical device means tools, instruments, devices, software, material or article used alone. In combination with specific equipment, e.g. software intended by the manufacturer to be used for diagnostic and therapeutic purposes in humans:
The registration of medical devices, including but not limited to those for implantation, in vitro diagnostics and various treatment sets, is mandatory and is regulated by the provisions contained in the Medical Devices Act of 20 May 2010 (Journal of Laws No. 107, item 679, as amended). The manufacturer and authorised representative based in Poland shall register such a device at least fourteen days before it is first handed over for performance evaluation or placed on the market. An importer having its registered office in Poland shall notify the President of the Office of a medical device intended for use in the territory of the Republic of Poland no later than within seven days of the date on which the first product is placed on the market in Poland.
Legal acts concerning the use of a medical device and registration of medical products are the Act of 20 May 2010 on medical devices (Journal of Laws No. 107, item 679, as amended), Regulation of the Minister of Health of 22 September 2010 on the amount of fees for notifications and notifications concerning devices and the amount of the fee for submitting an application for a free sale certificate (Journal of Laws No. 186, item 1251, as amended), Regulation of the Minister of Health of 22 September 2010 on the template of the CE mark (Journal of Laws No. 186, item 1252).
Specchem not only specialises in chemical consultancy, but also supports medical device manufacturers. Medical devices have to be certified when they enter the market. The certification programme takes approximately two weeks.
