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), are classified in Classes I, IIa, IIb or III, in accordance with the rules and principles laid down in the Regulation of the Minister of Health of 5 November 2010 on the classification of medical devices (OJ C 104, 11.12.2010, p. 1). 16 November 2010). In particular, to list A or to list B, as set out in Annex 2 to the Regulation of the Minister of Health of 12 January 2011 on the essential requirements and procedures for assessing the conformity of in vitro diagnostic medical devices (OJ C 104, 11.12.2011, p. 1). U. of 24 January 2011) in vitro diagnostic medical devices are also eligible which, in view of the serious consequences of an incorrect test result with their use, require specific conformity assessment procedures (Article 13(1)(a) and (b) of Directive 91/414/EEC). 20, 21 of the Medical Devices Act).

According to the above-described legal definition, the 'intended use' given to it by the manufacturer is essential for the qualification of a product as a medical device. In the event of discrepancies in the classification of a medical device or the classification of a medical device for in vitro diagnostics or an incorrect indication of the class of medical device or the misclassification of a medical device for in vitro diagnostics, the devices shall be settled or the devices shall be classified or qualified, by administrative decision, by the President of the Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products (Article 11). Article 22 of the Medical Devices Act).

Holler Box