Design & Development records for Medical Devices Packaging and Labelling

#1
Hi - I've always worked in organisations who follow the design and development process for packaging and labelling as well as the medical device itself, by which I mean they would have design requirements defined, design reviews and V&V activities completed, so a full set of records. While the FDA 21 CFR 820 does specifically call for aspects of their Design Controls to be applied to packaging and labelling, it is less clear in ISO13485.

I just wondered what other have experienced? Have you managed to get ISO 13485 accreditation without applying section 7.3 to packaging and labelling?
 
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shimonv

Trusted Information Resource
#2
Packaging and labeling validation is pretty much standard practice and notified body auditors expect to see that as part of design and development records.
 
#5
Thanks all. I appreciate it is a requirement for design outputs, and also validation as highlighted above, and in my experience auditors always look 'up-stream' so would look for the outputs to correlate to inputs, etc., but the inputs and design reviews are not explicitly stated as requirements in ISO13485. I've always known these records to exist for packaging and labels, but now work for a much smaller organisation and am conscious not to over-process if we can avoid it
 

Billy Milly

Involved In Discussions
#6
but the inputs and design reviews are not explicitly stated as requirements in ISO13485.
ISO 13485:2016 - 7.3.3 explicitly states inputs and 7.3.5. explicitly states design and development review. All the "shalls" are requirements.

Medical device = Actual device + IFU + labelling + packaging. So, when developing a medical, device, everything stated has to be included in the project (inputs, actions) and development file (records).

Option to avoid this would be useful for me too...
 
#7
Thanks Billy. This is certainly the way we are operating now, but I just wanted to confirm what others are doing. I.e. whether they put the packaging and labelling design through the entire design process, or just the specification and V&V sections. Looks like we need to keep operating as we currently are.
 

Tidge

Trusted Information Resource
#8
Thanks Billy. This is certainly the way we are operating now, but I just wanted to confirm what others are doing. I.e. whether they put the packaging and labelling design through the entire design process, or just the specification and V&V sections. Looks like we need to keep operating as we currently are.
Packaging and Labeling go through our design process. For what it is worth: packaging and labeling can also generate customer complaints and non-conformances... which ought to be enough motivation to put such things through design controls.
 
#9
Packaging and Labeling go through our design process. For what it is worth: packaging and labeling can also generate customer complaints and non-conformances... which ought to be enough motivation to put such things through design controls.
Yes, I completely agree. I think there is a real risk for regulatory requirements for what has to be detailed on packaging to be missed, hence I've always pushed for these requirements to be identified during the design input phase, then reviewed and verified prior to release.

I'm now sure we're doing the right thing, I was just curious as to whether others are being as thorough. We're just very, very small so don't have the resources of some of the big corporates I've worked for before.
 
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