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Making excellence a habit
In June 2011, DuPont announced that it is changing the manufacturing lines of Tyvek® 1073B and Tyvek® 1059B to use newer technology, in order to ensure consistent and flexible supply.
DuPont has been working with a number of European Notified Bodies from the start of this project, including BSI. After review of the transition plans, BSI published a positioning statement to ensure that medical device manufacturers impacted by this change understood the requirements for CE Marked devices.
The statement details requirements for manufacturers who hold Annex II.4 or Annex III CE Certificates to submit a change notification for review by their Notified Body.
With regard to Annex II.3, Annex V or Annex VI CE Certificates, the Tyvek® change is not considered a significant change, and does not need to be reviewed prior to implementation.
DuPont have now announced publicly that the equivalence test results indicate ‘Functional Equivalence’ between the current Tyvek® 1073B and Tyvek® 1059B material with the Transition Protocol Material produced by the new manufacturing process.
DuPont has recently announced that there are still specific situations where manufacturers are not yet ready to switch to the new Tyvek® 1073B and Tyvek® 1059B material and are continuing to make legacy Tyvek® available until end of the 2nd quarter 2016.
Any manufacturers that are impacted by the DuPont™ Tyvek® Medical Packaging Transition Project that have not already submitted change notification should contact their Notified Body to ensure approvals are in place before the legacy Tyvek® is discontinued.