Position Paper on Rule 14 of the MDR

AESGP Position Paper on Rule 14

AESGP Position Paper on Rule 14 concerns the classification on a case-by-case basis of medical devices composed of substances or of combinations of substances in accordance with the classification rule 14 set in Annex VIII of the Medical Devices Regulation (MDR) taking into account all their characteristics, including in particular their intended purpose and their inherent risks. Its main purpose is to provide actors of the MDR implementation with AESGP’s views on the pragmatic, proportionate and science-based interpretation of this classification rule when it comes to substances based medical devices.


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