MDR Quality System RequirementsĪrticle 10 is the section of the MDR that defines the obligations for device manufacturers to create quality system procedures, but a labeling procedure is not specifically mentioned. In 21 CFR 820.120, the FDA states that “each manufacturer shall establish and maintain procedures to control labeling activities.” But there is no similar requirement in the MDR. ISO 13485:2016, clause 7.5.1 states that you shall implement “defined operations for labeling and packaging,” but the standard doesn’t specifically say that “the organization shall document procedures” for labeling. In fact, the MDR doesn’t even specifically require that you have ISO 13485:2016 certification. The MDR does not actually include a requirement for a labeling procedure. The topic of this article is how to create an MDR labeling procedure for compliance with Regulation (EU) 2017/745 (MDR) for CE Marking of medical devices. Don’t forget to subscribe to our YouTube channel for more medical device quality and regulatory training.
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