Packaging and Labelling Regulatory Reporting

[jennaleeb]

Hi there! We are a small manufacturer of Class I sterile medical devices. We want to offer our customers customized packaging (different sized boxes, labelling languages, different pictures for the IFU, etc) depending on their needs.

What does this mean from a regulatory perspective? If the device is CE marked do we have to notify the CA/NB every time there is a new packaging configuration if it does not affect risk/product quality/etc?

THANKS to everyone who posts on this forum!

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Sam Lazzara]

Always a good idea to ask your Notified Body what they expect. Being a relatively low risk class is in your favor but you will still need to list all REF items in your Declaration of Conformity and make sure each REF is addressed in your Technical File. In my experience, which is mostly Class IIa or higher risk classes the NBs want to pre-approve the addition of new REF items.

 

[pkost]

NB's authority is limited to the assessment of the sterility aspects for Class I (sterile), although this can be quite far reaching

your main concern is that changing the size of the box is not going to affect your packaging validation as this may impact on sterility

 

[Pads38]

How about creating a check list of all the elements of information that your packaging must show?
Then for each design you can tick off each element.

 

[jennaleeb]

That's a great idea! Thanks for everyone's input. We are not actually changing the first layer of packaging (the sterilization pouch), just the "decorative exterior" if you will. The check-list idea is perfect.

Regards,

Jenna

 

[pkost]

Be sure to evidence and justify that your box is only decorative and does not provide any protection to the sterile pouch! I have rarely come across a box/carton in medical devices that are only decorative

 

[MIREGMGR]

Doesn't your ISO 11607 validation include distribution cycle testing for your customer's marketing geography-scope? How do you do do the distribution cycle without the case being involved?

Or do you mean that you're double-casing, and the inner case by itself is sufficient for the distribution cycle...?

 

[jennaleeb]

Yes exactly - the individual devices are packaged in pouches according to validated ISO 11607. They could be mass shipped as such. But some of our customers require each device to be placed in customized boxes.

 

[MIREGMGR]

Yes exactly - the individual devices are packaged in pouches according to validated ISO 11607. They could be mass shipped as such.

My interpretation is that ISO 11607-1 Section 6.3 requires that the packaging system (i.e. the case) be performance tested and qualified as a part of overall sterile barrier system validation. ISO 11607-1 does not discuss the "distribution cycle" concept as the underlying foundation for such performance testing, but other standards do.