Packaging Requirements for Non-Sterile Class II Medical Devices

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Ronen E

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Hello

Just to pick up on this theme of packaging, I am classifying the packaging of a non-sterile Class II device for the EU market.

Our device (1x3x3 cm) is wrapped in medical grade bubble wrap and placed in a medical grade box. I have 3 questions:

1. The primary packaging is the bubble wrap. Is there a requirement for labelling?

2. The box is required to protect the primary packaging and stop it unfolding (i.e. the bubble wrap is not stand alone in protecting the device as a blister pack would be). Is the box considered as primary or secondary packaging?

3. The device is currently labelled with a super-small copy of the box label. Would it be sufficient to label with the LOT number?

Thank you in advance for your help!
Hi, sorry for not picking this earlier.

My answers:

1. Unless the bubble wrap is premade into a little closed bag or a pocket, or is permanently secured after being wrapped around the device (eg heat sealed), ie it is just a loose piece of bubble wrap that is wrapped around the device and held only by means of it sitting inside the box, I wouldn’t consider it a packaging level at all and it wouldn’t require any labelling whatsoever. The guiding question should be “can the device reasonably end up being circulated in this supposed-packaging-level alone?”, and I suppose in your case the answer is “no” because it would simply fall off.

2. Given my opinion above, the box is your primary packaging (you may consider the bubble wrap inside an integral part of it, for analysis simplicity).

3. Most advanced regulatory systems require that the “label” contents are on the device itself unless it’s impractical. It sounds like in your case it is practical, so it should be there. The only exception that comes to my mind is that in some systems there’s an explicit requirement not to use font size smaller than 1mm - if you have done that it can be an indication that such labelling is impractical, which normally allows you to move it to the next level - the box in your case. Most systems also require that the label is legible (and some parts are conspicuous/prominent) so you can go by that to your advantage, too. Whether or not the lot number is required is a separate question, but if it’s required on the box and you end up labelling the device too, it would also have to be on the device.

Cheers,
Ronen.
 
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