Definition of "the label" as referenced in Annex I (13.3) of MDD 93/42/EEC

[mr.mike]

Apologies for such a simple question, but what is the definition of "the label" as referenced in Annex I (13.3) of MDD 93/42/EEC?

Can this be the packaging label, or does it necessarily refer to a label physically attached to the device itself?

I had started a discussion thread awhile back regarding labelling of small devices (Labeling a Small Class IIb Medical Device).

Based on the discussion there, I would presume that interpreting "the label" to mean "the packaging label" would be acceptable (as, for example, in the case of a small device, including the "special operating instructions" (13.3(j)) on the device itself would be impossible).

But if this is the case, is there not requirements specific to labels on the device itself? It makes sense to put a serial number on each device (for recall purposes), but other than that can the device itself be completely label-free, with all the information required by Annex I 13.3 being on the packaging label?

Appreciate any thoughts...
Thanks.

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

[Ronen E]

In Reply to Parent Post by mr.mike

Apologies for such a simple question, but what is the definition of "the label" as referenced in Annex I (13.3) of MDD 93/42/EEC?

Can this be the packaging label, or does it necessarily refer to a label physically attached to the device itself?

I had started a discussion thread awhile back regarding labelling of small devices (Labeling a Small Class IIb Medical Device).

Based on the discussion there, I would presume that interpreting "the label" to mean "the packaging label" would be acceptable (as, for example, in the case of a small device, including the "special operating instructions" (13.3(j)) on the device itself would be impossible).

But if this is the case, is there not requirements specific to labels on the device itself? It makes sense to put a serial number on each device (for recall purposes), but other than that can the device itself be completely label-free, with all the information required by Annex I 13.3 being on the packaging label?

Appreciate any thoughts...
Thanks.

Hi,

In my understanding, "the label" is any print on the device itself; anything else could only come under "labeling" (or "labelling", depends where you come from...). Only when labeling of any sort is impossible / impractical on the device itself, the immediate packaging label can take on the role of "the label".

Cheers,
Ronen.

[PaulGr]

If you are not able to get all the required 'label' information on the device, I would advice to argue in the risk management file why that's acceptable. It will depend on the circumstances: a single use device that is unpacked just before use will lead to lower risks than a device that's in a hospital for several years without it's initial packaging.