EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state

[aravindh]

Annex I section 11.3 states "Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer."

What is a medical device with 'specific microbial state'?

whether it is a sterilized device or not?

 

[chris1price]

I "assume" it means the device is sterile, I suppose it could also include clean or another microbial state. I can only think of an Biological Indicator?.

11.4, 11.5 and 11.6 are all variations on different aspects of sterility. I am not sure why 11.3 is worded different.

 

[Marcelo]

The most obvious is a sterile device, but even so, devices may have different sterility assurance level, so any level, would be a different state.

You may also have device which have other, different, specific defined microbial states.

 

[Ronen E]

Could be a specified Bioburden level.

 

[Nissim Shaked]

What about a device which was assembled in a clean room and its CFU<1000 ?
I think that it should also be mentioned as effected by MDR-Annex I section 11.3
In such a case why should add a label stating no breaks/punchers shall be found in the device primary packaging.
As well as the used by date information.

 

[indubioush]

Reference the symbols in ISO 15223-1, which include the following:
Sterile
Sterilized using aseptic processing techniques
Sterilized using ethylene oxide
Sterilized using irradiation
Sterilized using steam or dry heat
Non-sterile
Sterile fluid path

To comply with the requirement that sterile medical devices..."remain so under the transport and storage conditions specified by the manufacturer," medical device manufacturers must include sterilization tests in their real-time aging studies to ensure a medical device remains sterile during the entire shelf life.

 

[Nissim Shaked]

 

[SylvieS]

The explanation of the BSI guidance: (sorry do not have the right to post the link, to download the full guidance)

"SPR 11.3 is new requirement for devices with a ‘specific microbial state.’ This may be interpreted as a clarification, given that some devices (such as filter-sterilized liquids) have a different sterility assurance level. This requirement is considered to clarify that the microbial state should be defined and properly validated."