Packaging specifications for sterile and non-sterile medical devices


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Hi all,
I would like to understand more about requirements for Packaging specifications for sterile and non-sterile medical devices. In particular, I would like to understand if packaging specs must be part of design and development documentation, or can they be handled by the manufacturing process team? In other words: should packaging specs be part of the DHF, or can they be part of DMR only? By reading FDA regulations, it seems that they need to be part of DMR only, but... I have some spare questions:
1- I often read that "by definition, medical device consists of the device itself, packaging, labelling and IFU." Is that stated in any regulation/standard?
2- Are user needs and requirements (typically considered as part of DHF) required as an input to define packaging specifications?
3- Do packaging specs (and VnV activities) need to be part of the I/O matrix?
4- If I need to include packaging specs in the DHF - can I avoid to include there the configuration of the packaging (how devices are distributed and protected inside packaging)?
5- Do I need to include brands of packaging material in the packaging specs (and do I need therefore a Design Change project every time one of these materials - or the configuration - is changed)?

In principle, it does not seem logic to me to managing packaging changes in the DHF, through Design Change projects... but it seems that NB auditors expect that, so I am afraid that a "DHF-control system" is needed.
A lot of questions, I see... any answer (in particular if supported with references to regulations/standards) would be highly appreciated. Thank you!


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I had some time to have a look at in the weekend, and I found some answers. I want to add it here, to reduce my list of questions, but also hoping it might be useful for other quality lovers!
1- From the document above: § 820.3(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
2- As far as I know, Validation is required AT LEAST for sterile packaging. Therefore, user needs on sterile packaging is clearly needed. I am not sure about packaging for non-sterile devices.
3- Yes (at least if dedicated user needs are required).
4/5- My feeling is that the information included in the DHF shall be sufficient to ensure the safety and effectiveness of the packaging. Whether this includes configurations and brands, it depends on our ability on describing the packaging system at such a level to allow us to complete VnV activities...


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I think you have answered your own questions, but yes, the packaging and labelling need to be defined in the Device Master Record, which is part of the Design Outputs and recorded in the Device History File.

The packaging of both sterile and non-sterile product needs to undergo verification and validation. This should include shipping tests, shelf-life tests and where applicable sterility testing, to ensure the finished packaged product always meets specifications..

Validation of packaging and labelling should include user requirements (part of Design Inputs), such as can the user open the packaging, can they read and understand the label and follow instructions, etc.

Any changes to packaging and labelling should reference back to the DMR and give consideration to repeating V&V testing. Not performing re-validation is a very common 483/warning letter issue.

Note, DHF, DMR etc are defined under FDA, 21CFR820, and not under ISO13485, where the question was raised.


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Although DMR is becoming MDF and is now being defined in 13485 only (eliminated in QMSR) and DHF is becoming DDF and is also being eliminated in QMSR
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