Guide to Package Integrity & Validation Testing under ISO 11607 and MDR

Updates to ISO 11607, Parts 1 and 2, have left many medical device manufacturers wondering about the future of their packaging designs. These changes come at a stressful time for OEMs, as Europe is also in the process of replacing the current Medical Device Directive (MDD) with the Medical Device Regulation (MDR) in 2020. The interplay between ISO 11607 and MDR is complex, and it’s difficult to predict regulators’ plans for enforcement.