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Additional Information

Summary of the description of the URPL Office related to medical devices:

President of the Office is a government administrative authority, competent for matters concerning marketing and use of medical devices – within the meaning and on the basis of the Act on Medical Devices of 20 May 2010 (O.J. No 107, item 679) and clinical trials within the scope determined by the Medical Devices Act of 20 May 2010.

The Office is a public administration body supporting the President of the Office in realization of the above matters.

The rules and the scope of responsibilities is determined by the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products