DuPont™, the company that manufactures Tyvek® (a packaging material widely used by medical device manufacturers), announced in 2011 its decision to replace their Legacy Tyvek® with the new Transition Tyvek®.
From a regulatory point of view, this change directly impacts Medical Device (MD) manufacturers that use Legacy Tyvek® in their products. Therefore, DuPont™ set up a transition program called the « Medical Packaging Transition Project » (MPTP) to help them implement this significant modification.
Quick Reminder of the Tyvek® Transition
DuPont™ has published a series of essential guidelines and documents to help MD manufacturers ensure the ongoing compliance of their devices that use Tyvek® and to minimize costs. During the transition, manufacturers must evaluate, validate and demonstrate the interchangeability between both types of Tyvek® in their technical documentation.
Let’s not forget that the Transition was supposed to take place by June 2016 but DuPont™ decided to continue Legacy Tyvek® distribution until 2017, and possibly even 2018. This way, MD manufacturers have more time to integrate the interchangeability into their documentation.
If you use Tyvek®, take a look at our presentation. You will find an overview of the Tyvek transition and links to all the documents available to help you stay in conformity.
Find here an updated version of our may, 18th 2016 presentation on Slideshare.
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