ISO 11607 and MDR—package testing and validation impacts
Medical device manufacturers around the world are working to ensure their package designs are in line with the recent updates to ISO 11607, Part 1 and Part 2, and the Medical Device Regulation (MDR). Britt Jones, WuXi AppTec’s manager of package testing services, answered five key questions about the ISO 11607 revisions to help explain how they will affect your products and preclinical device safety test plan under MDR.
1. What are the goals of the revisions to ISO 11607, Part 1 and Part 2?
The changes are designed to enhance patient safety and create globalized harmonization with other standards. By putting stricter packaging requirements in place, product handling by clinical professionals will be more intuitive and contamination risk will be lowered.
2. What’s the interplay between these changes and MDR?
Updates to ISO 11607 should help with MDR compliance because the goal of the revisions is to harmonize the standards with the General Safety and Performance Requirements of the MDR. From an MDR standpoint, packaging failure or the inability to demonstrate package integrity per the revised standards could have serious business implications. Noncompliance could result in a product being pulled from market, unforeseen costs associated with package redesign and/or retesting, or brand reputation damage if packaging fails and causes a patient safety issue. While the requirements align closely, testing procedures vary. Under ISO 11607, testing will be required for manufacturers to comply; but, under MDR, retesting is not necessary unless thorough justification isn’t possible with currently available data. Because many legacy products under MDR will require more evidence than what exists in company records to comply, in most cases, testing will be inevitable with both standards. Determining the required tests for validation under ISO 11607 will involve a risk analysis under ISO 16775.
3. How will new usability requirements impact package instructions and testing?
The goal of the usability requirements is to provide clinical staff with necessary instructions for use. Instructions must identify a clear location on the package to begin opening it, provide instructions on the opening technique, and describe how to present the product into the sterile field while preventing contamination and damage to the contents. Proper instructions for use are critical to infection prevention efforts and patient safety. Also, manufacturers will now be required to complete usability studies that prove the instructions are effective and intuitive.
4. In what ways have sterile barrier system requirements intensified?
Regulators now need to see that a sterile barrier system’s configuration will remain intact and prevent the possibility of microbial contamination. Packaging should guide clinicians on how to inspect package integrity before use to ensure contents are presented aseptically. And packaging should provide clear steps for safe and proper use, so that the product remains sterile from the time the barrier is broken to when it’s used.
5. How has terminology changed with the updates?
The terminology used by various regulatory bodies has been inconsistent in the past, but the changes to terminology in ISO 11607 will finally create alignment. The language also aims to harmonize definitions with ISO 11139 and establish a globalized understanding around proper packaging, labeling practices and integrity testing
It’s important to understand that device history files and regulatory submissions are not complete without package validations. Ensuring all your devices and packaging are compliant with updated standards by the May 26, 2020 MDR deadline probably seems daunting, but you don’t have to go through the process alone. For more information or to secure your spot in line with WuXi Medical Device Testing, visit https://medicaldevice.wuxiapptec.com/contact-us/.
WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.