Updates to ISO 11607 and ISO TS 16775, standards covering packaging for terminally sterilized medical devices, may help manufacturers comply with EU Medical Device Regulation set to go into effect next year.
With an application date of May 2020, the new EU Medical Device Regulation (MDR) is fast coming down the pike—a daunting prospect for medical device manufacturers. But updates (one published and one still undergoing revisions) to two standards covering packaging for terminally sterilized medical devices could help prepare the industry for compliance with the new European rules.
Speaking at the HealthPack conference in Portland, OR, last month, Thierry Wagner, regulatory affairs director for Europe, the Middle East and Africa for DuPont Medical and Pharmaceutical Protection, explained that revisions to ISO 11607-1/2 and ISO TS 16775 were written to harmonize with the General Safety and Performance Requirements (GSPR) contained in the EU MDR.
“Harmonized standards will be the means to demonstrate compliance with these GSPRs,” writes Daphne Allen, executive editor of Packaging Digest sister publication MD+DI.
ISO 11607-1/2: 2019, “Packaging for terminally sterilized medical devices,” was published February 4, and some revisions of the standard stem from the EU MDR GSPR stipulations that a design “allow for easy and safe handling and . . . prevent microbial contamination,” and “that the integrity of that packaging is clearly evident to the final user,” according to Allen’s recap of Wagner’s talk.
A provision in ISO 11607-1:2019, “Packaging for Terminally Sterilized Medical Devices — Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems,” directs packagers to complete a documented usability evaluation for aseptic presentation in either a real or simulated-use environment. That requirement is in line with the EU MDR directive that medical device manufacturers find ways to improve usability in case of unfavorable post-market surveillance feedback from end users.
Other notable changes in ISO 11607-1/2:2019 that Wagner, who serves as convenor of ISO TC 198/WG7 “Sterilization of Health Care Products—Packaging,” called out at HealthPack include the following:
• Formal inclusion of risk management.
• A new annex on ways to differentiate a sterile barrier system from protective packaging.
• A new section on visual inspection.
• A section on design changes and validation.
• A revised section on process validation that includes the new concept of a process specification.
• A new annex on environmental aspects according to ISO and CEN guidance.
The EN ISO versions have not yet been published, but Wagner said the EU committee in charge of EN ISO 11607 was set to meet with a consultant last month to work on harmonization with the EU MDR.
Also still under revision is ISO TS 16775, “Packaging for Terminally Sterilized Medical Devices - Guidance on the Application of ISO 11607-1 and ISO 11607-2.” A new effort led by Wagner is seeking to develop a symbol to enable users of sterile packaging to distinguish a sterile barrier system from a protective layer and help packagers comply with the EU MDR Annex I Section 23.3, which requires indication of a sterile barrier. To learn more about the proposed symbol and what else to expect from the ISO TS 16775 revision, check out the story on MD+DI.
Jamie Hartford is content director for Packaging Digest’s parent company, UBM Americas, Advanced Manufacturing Group.