Our medical device does not contain or use any sterile components or parts. We are getting ready for our initial submissions for ISO and CE and we are a bit confused as to if we really need to validate our packaging or just have the packaging detailed in our technical file.

Any help would be greatly appreciated.

820.130 Device packaging: Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.

Please read the advice from the Medical Device School (http://medicaldeviceschool.com/820_130%20Device%20packaging.html) (I am no associate)

For testing guidance reast ASTM D4169 (http://www.astm.org/Standards/D4169.htm)

Yes.

EU MDD Annex I, section 8.6:

Packaging systems for non-sterile devices must keep the product
without deterioration at the level of cleanliness stipulated and, if the
devices are to be sterilized prior to use, minimize the risk of microbial
contamination; the packaging system must be suitable taking account of
the method of sterilization indicated by the manufacturer.


You would need to prove the underlined bit. At the bare minimum you would need to prove that shipping your product does not damage it or affect its intended use. If you have more stringent requirements (cleanliness or whatever) you'd have to prove those as well.

:2cents:

Our medical device does not contain or use any sterile components or parts. We are getting ready for our initial submissions for ISO and CE and we are a bit confused as to if we really need to validate our packaging or just have the packaging detailed in our technical file.

Any help would be greatly appreciated.
Your notified body for the CE will be the best agency to take this question. Again do you have enough data that the present packaging detail that you describe in the Tech file has been working good for you without any complaints ? Without knowing what your medical device is and its requirement to meet any established standards, only a general response may perhaps surface. Just to say again that packaging of medical devices is a very important aspect and many a times neglected also right from the design .....