Package Validation requirements for Medical Devices CE Marking and FDA

Medical Devices have a specific life time and it is the responsibility of each manufacturer to make sure the device performs its intended use during this period. So, Regulatory Bodies are concerned that the terminally sterilized medical Devices are stable throughout their shelf life. The major failures occur due to the inadequate packaging of the device due to improper validation. Medical Device packaging is not standardized as in the shelf life requirements. In order to validate the packaging the best practice is to validate by physically testing the sealing parameters. These reports needs to be included in the technical file/Dossier

All materials such as plastics, polymers, and adhesives degrade over time. The medical devices have a primary and a secondary packaging system and validation should be done for both of them. Basically all the validation programs must satisfy and completely reduce risks identified through the risk assessment process. In case of combinatory products ICH guidelines needs to followed to makethrough the product is stable throughout the shelf life. In cases where the products have a drug coating a combination of Shelf life as well as the ability of the drug stability needs to be taken into account throughout the manufacturing as well as sterilization processes.

All the medical device packaging validation needs to be considered with the normal products and non-sterile samples. When the samples after sterilization are sent for secondary testing reveal the degradation caused when an accelerated or real time study is conducted. Also samples during different stages of transportation needs to be taken for analysis. Packaging testing guidelines can be followed from the ISO 11607 which describes the ASTM tests. Also many aspects of packaging such as material qualification, validation of seal, integrity are taken into account.

Several physical tests such as burst, Creep, leak and peel tests are usually performed. It is best advisable to do prior research and contact a specialist to identify and understand the tests that are needed as a part of the validation program that needs to be included in the technical file for CE marking and FDA submission.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jr@i3cglobal.com