Packaging Requirements for Non-Sterile Class II Medical Devices

[maple68]

Hi,

We are about to putting our Non-sterile, class II hand- held medical device on the market. I was asked to look into the packaging requirements. I understand the labelling requirements. But I have no idea what packaging requirements may be applicable to us. I appreciate your help and advice on this.
Thanks a lot,
Maple

 

[pkost]

There are no specific requirements for the packaging. However, it must not be detrimental to the function and efficacy of the device.

i.e. If drops and knocks will damage your device, your packaging must be sufficiently padded to prevent this damage occurring

Or, a more interesting one that I came across recently - if your device is available in both sterile and non sterile, do not package your non-sterile device in something that could be construed as sterile packaging...it avoids confusion and reduces risk!

 

[maple68]

Thanks a lot for your reply. It's helpful.

May I please ask a further question?

It look there are no specfic requirements for our non-sterile device; however, if we need to decide the packaging, such as, what's the material for the box? what's the filling to protect the device, any drop or vibration test? and etc. what should we do. Do we need to work closely with the packaging supplier to decide?or we need to have somebody design for us.

Thanks again for any advice,

Maple

 

[pkost]

ER 3 states:

The devices must achieve the performances intended by the manufacturer
and be designed, manufactured and packaged in such a way
that they are suitable for one or more of the functions referred to in
Article 1 (2) (a), as specified by the manufacturer.

Your packaging must therefore be sufficient to protect the device and you must be able to demonstrate that you meet this requirement. How you do that is up to you.

If you can demonstrate that your device is ok being wrapped in tissue paper then that is fine. If you decide that it needs to be packaged in a metal crate with integral suspension then that is fine too - it is really up to you!

With regards to how to demonstrate that it is capable, there are 3 methods I can think of off the top of my head:
1. the easiest (but least thorough) is taking using the packaging solution for another product that has similar concerns during transportation/storage.
2. If that isn't possible you could do a variety of tests, depending on what your risk assessment has identified as a possible cause of failure - drop test, vibration test, thermal/humidity test, pressure test etc.
3. Package up your device and send it out with your standard couriers to your most obscure location, then get it sent back


With regards to whether you should work closely with your packaging supplier or get someone to design it for you...I can't answer that, all I can say is that it is important that it is done right!

 

[maple68]

Thanks a lot, Pkost.

Those three sugestions are very practical. We will go from there.

Thanks again,

 

[mhkeerthi]

Maple,

However it gets mandated to have the package qualified by scientifically getting it tested by means of standards compliance through accredited labs as the equipment's used for testing should even be calibrated (when you come across UL / CB or FDA regulations).

Here are few standards that most medical device companies follow:
International Safe Transit Association
ISTA 1A - ISTA 2A - ISTA 3A

and / or you can also refer to the following ASTM standards as applicable to your device.
ASTM-D3078
Bubble Emission Leak Test
ASTM-D4169
Distribution Simulation Testing
ASTM-D4728
Random Vibration Testing
ASTM-D5276
Drop Test
ASTM-D642
Compression Test
ASTM-D999
Vibration Testing

 

[maple68]

Thanks a lot, mhkeerthi. Greatly appreicated your comments. This is really helpful. I'm working on the test protocol...

 

[csa14]

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!

 

[TempusVernumProcella]

Help? I have a similar question regarding device packaging but don't know how to start a new thread...

 

[Mark Meer]

...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?

In my opinion, the whole thing (bubble-wrap + box) would be considered the "primary" packaging. Other levels of packaging generally refer to different configurations (e.g. a kit), or multiple units (e.g. cartons, shipping containers).

For the most part, the regulations don't specify different requirements for different levels (the UDI requirements being a noticable exception), and much of the information requirements are stated like "on device and/or packaging", so you can put on either device or package.

That being said, where/how your device is intended to be sold should be considered. Is it intended for over-the-counter sale to the general public? Will is be sold in the US? The US FDA (for example) has some very specific requirements in this case.

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?

The system of identification and traceability is up to you, as long as requirements are met. For a Class II, there isn't any requirement for serial numbers, so LOT numbers should be fine assuming you have no reason to increase the level of traceability.