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Packaging Cliffs Notes: MDR’s Pertinent Updates

Live from PharmaPack Europe, Thierry Wagner lists the key MDR safety and performance requirements for sterile medical packaging and talks sterile barrier symbols.

Last September, Healthcare Packaging interviewed Kelli Anderson from Network Partners on details of the new EU Medical Device Regulation, which replaced the existing Medical Device Directive [See Part 1 and Part 2 of that interview].

At PharmaPack Europe, Thierry Wagner, Regulatory Affairs Director, Europe, Middle-East & Africa, at DuPont Medical and Pharmaceutical Protection gave quick takes for packaging professionals, and discussed a new sterile barrier system symbol in the works. He noted that validation of packaging is a clear requirement, on the same level as sterilization, and that the focus on the life cycle of the device includes the design and entire lifetime of the packaging. Scroll below for a piece of advice on validation...

Previous: “…eliminate, or reduce as far as possible, the risk of infection to the patient”

New: “Design shall allow for easy and safe handling and… minimize microbial contamination

 

Previous: “…remain sterile, under the specified storage and transport conditions:”

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LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast