Poring over the new requirements in the MDR, in particular, Annex I. Item 11.4 states:
Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user. (emphasis added).
Curious what everyone thinks would constitute "clearly evident" related to (loss of) packaging integrity? By and large, a small puncture wouldn't be "clearly evident" (at least in the few sterilized devices I've worked with).
Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user. (emphasis added).
Curious what everyone thinks would constitute "clearly evident" related to (loss of) packaging integrity? By and large, a small puncture wouldn't be "clearly evident" (at least in the few sterilized devices I've worked with).