Sterile device packaging under MDR


Staff member
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).


Starting to get Involved
This is an update on Item 8.3 from Annex I Essential Requirements from the MDD.

My interpretation of Annex I. Item 11.4 MDR is that the sterile device must clearly display some sort of tamper evidence, rather than some intricate way to show a small puncture.
I too have looked at this statement and have no idea how to meet its intent. "Tamper Evident" is to ensure the contents have not been interfered with, and not the integrity of the sterile barrier. I struggle to think how the final user will assess the integrity of a standard blister or pouch.

Any ideas would be welcome?


Starting to get Involved
The national working group for implementation of the MDR/IVDR of the German Ministry of Health made an interpretation for this requirement as part of their FAQ on manufacturers' duties:

Here is my personal translation of their answer:
"This new/changed requirement has to be understood in the way that manufacturers shall design packaging in a way that users are able to detect damages and especially unintended opening of the packaging. This means e.g. that sterile packagings shall not be resealable."

This answer is not really satisfying but it is a starting point. It does not look like the CA's (at least the German one) are trying to enforce markers or other costly measures of manufacturers.

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