How the MDR changes impact your packaging validations
Understanding the changes that are being implemented as part of the Medical Device Regulation (MDR) updates for packaging validations can be challenging. Nelson Labs has a team of experts available to help manufacturers bring currently validated packaging systems into compliance with the new requirements along with providing test plans for new sterile barrier systems that are built to meet the standards.
NEW LANGUAGE
The addition of the word “packaging” and other packaging-related terms in the MDR requirements may seem simple, but the new language has important implications for device manufacturers: manufacturers must have data on the integrity of the sterile barrier with justification and results available for regulatory review.
The MDR focuses on the entire lifecycle of the device, which puts emphasis on the importance of the package maintaining the sterile barrier from its manufacture through the point of use. Evaluation of the packaging system needs to include data that demonstrates a successful challenge to the packaging system from distribution and handling through the established product expiry date.
The regulation states that, “…devices labelled as sterile shall be processed, manufactured, packaged and sterilized by means of appropriate validated methods.” The important implications here are that manufacturers use the recognized test methods listed in harmonized standards to demonstrate compliance of packaging as a sterile barrier system. This change is evident when looking at the qualification process notified bodies need to meet to evaluate devices for market sales. Providing “specific qualification criteria for the assessment of packaging” has been outlined as a primary goal when performing onsite device manufacturer visits.
Our team can evaluate changes in regulatory standards which previous testing followed compared to the most current regulatory standards, including:
GAP ANALYSIS
- Review of each standard which previous testing followed and new regulations that may now apply to the device packaging
- Review of final test reports previously performed
- Recommendation of any testing needed to bring your packaging into compliance with the most current standards
LIFE CYCLE TESTING APPROACH
Manufacturers benefit from the established test plans and processes in place at Nelson Labs. As part of our process, we perform validation testing using a focused lifecycle approach.
- Test Plans – We create test plans that consider the design and validation of the packaging over its lifetime. We start with evaluating the design of the packaging, assessing sterilization compatibility, and establishing expiration dates.
- Distribution Hazards – Documented evidence regarding the shipping environment, including temperature excursion studies, demonstrates compatibility to ensure that the packaging will protect your product to the point of aseptic presentation in the field.
- Prevention of Microbial Barrier Contamination – We have a complete offering of microbial barrier tests to complement most packaging configurations including flexible and rigid containers.
Understanding these new regulations and getting prepared to meet them is no small undertaking. That is why the expert advisors at Nelson Labs are ready to help you understand your testing needs and get your products certified and safely to those patients who need them.
Let us help you create a gap analysis and a clear strategy for meeting the new MDR.
