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Art. 15 Classification
1 Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. This classification must comply with the provisions of Annex VIII to EU-MDR36. 2 ...37 36 See the footnote to Art. 4 para. 1 let. f. 37 Repealed by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, with effect from 26 May 2022 (AS 2022 291). |