Revision of EN ISO 11607, the guiding standard for medical device packaging, is progressing toward completion later this year. With many of the changes prompted by EU’s new Medical Device Regulations (MDRs), could harmonization with the EU’s new law be next?
ISO Technical Committee 198 Working Group 7 met earlier this year in Copenhagen to resolve comments received after ISO 11607’s Draft International Standard (DIS) document was balloted last year. The next step will be to finalize a Final Draft Standard (FDIS) for ISO Central Secretariat to review and then send out to ISO members for final balloting this summer.
Michael Scholla, global director, regulatory standards, and Thierry Wagner, regulatory affairs director, EMEA, both with DuPont Protection Solutions, discussed the unfolding developments at HealthPack in March. Scholla also serves as global convener of ISO TC 198 WG 7.
EU’s regulations were top of mind during ISO 11607’s revision. Wagner called the rules “new-approach regulations,” meaning that the law is meant to provide “high-level” Essential Requirements while leaving the details to harmonized standards. If harmonized standards are considered insufficient to meet the law’s high-level expectations or if there are no harmonized standards, the law provides the authority to the EU Commission to develop Common Specifications, which could direct medical packaging decisions.
To avoid these Common Specifications, which some experts worry could be overly prescriptive, the working group is aiming for a standard that could be harmonized. The EU commission has rejected many proposed standards for harmonization under the current law, the Medical Device Directive (MDD), and is working on establishing a new system for harmonization of standards with the new law, the MDR, while applying a much more rigorous approach, Wagner told PMP News.
Revisions were made specifically to support compliance with the EU MDRs emphasizing packaging validation and usability for aseptic presentation. For instance, the MDR expects that sterile packaging designs allow for easy and safe handling to eliminate or to reduce as far as possible the risk of infection to patients. It also requires that contents remain sterile under the transport and storage conditions specified by the manufacturer until the point of use and that package integrity is clearly evident to the final user, Wagner explained. To align with these expectations, ISO/FDIS 11607:1 currently states that “A terminally sterilized SBS with its protective packaging, if included, shall be designed to maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.”
To address usability, ISO/FDIS 11607:1 currently outlines in section 7 under “Usability evaluation for aseptic presentation” that “a documented usability evaluation shall be conducted to demonstrate that the sterile contents can be aseptically removed from the sterile barrier system for presentation.” Such an evaluation shall include an assessment of “the ability to identify where to begin opening,” “the ability to recognize and perform the technique required to open the sterile barrier system without contaminating or damaging the contents,” and “the ability to subsequently present the contents aseptically." If instructions for use for aseptic presentation are required to support the user, then the ability to follow these instructions and successfully open and present the contents shall also be evaluated.
The MDRs also outline expectations of “adequate” packaging validations and inclusion of validation reports, with respect to packaging and maintenance of sterility into the technical documentation that will be reviewed in the frame of quality management system audits, Wagner told PMP News. To align with these, ISO/FDIS 11607:1 currently states that “packaging systems that meet the requirements of design, usability, performance testing, and stability testing shall be considered validated.” Sections on documentation have been aligned with terminology of quality management system standards. ISO/FDIS 11607:1 includes a new section on packaging system design change control.
While ISO/FDIS 11607 is intended to address the EU regulations, it is expected to support packaging efforts outside European Union markets, too. Scholla emphasized at HealthPack that “the purpose is to create a global standard,” he said.