Title: Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR

Britt Jones, Manager of Package Testing Services, WuXi AppTec 06.13.19 With recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR) on track to replace Europe’s current Medical Device Directive (MDD) in 2020, medical device manufacturers are working hard to ensure their package designs are in line with impending regulatory changes. In short, updates to ISO 11607, Part 1 and Part 2, introduce stricter sterile barrier requirements and techniques for introducing devices to the sterile field, thus potentially requiring time-consuming package redesigns and revalidations, which is why it is important to think about testing and validations now. Ultimately, updates to ISO 11607 should help manufacturers comply with MDR, as the goal of the revisions is to harmonize the standards with the General Safety and Performance Requirements of the MDR.

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   Person Information
   Application Sequencing
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • ISO/Int'l.Organ.Standardizatn.


  • Packaging

  • Testing

  • Validating


  • Standards




  • MPO


  • 6/1/2019


  • Article