Virtual Engineering Week | Developing International Consensus Standards for Sterile Packaging Meeting Regulatory Requirements

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Nov 30 - Dec 4, 2020

6 Connected Industries. 1 Virtual Event.

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Virtual Engineering Week is bringing a full week of best-in-class education to the global design, engineering, and manufacturing communities. Join us each morning to hear from medical device industry professionals during the Medtech Mornings series, and in the afternoons to learn from engineering and manufacturing experts in areas like 3D printing, smart manufacturing, packaging, materials and sustainability, and career development.

All times listed below are PST (Pacific Standard Time).

Developing International Consensus Standards for Sterile Packaging Meeting Regulatory Requirements

Thierry Wagner  (Global Director Regulatory & Standards - Healthcare, Dupont)

Date: Wednesday, December 2

Time: 10:00am - 10:30am

Track: MedTech Mornings: Medical Packaging

Vault Recording: TBD


One of the objectives of the most recent revision of ISO 11607, "Packaging for Terminally Sterilized Medical Devices," published in February 2019, was to meet all packaging-related expectations outlined in the EU Medical Device Regulation. After further review, it was determined the risk management language wasn't compliant. In the meantime, the European version, EN ISO 11607-1/2 was published in January, 2020. Additional language on risk management has also been added to the working draft of ISO TS 16775, currently under revision.

Hear from industry expert Thierry Wagner about:
  • The new EU MDR: requirements for risk management and medical packaging
  • ISO 11607-1/2: 2019 has just been published and we are already amending it! The focus is to add more details on risk management over the medical packaging life cycle
  • Packaging sustainability: enabling a circular economy, supporting the UN sustainable development objectives, thoughts on future standardization activities