Packaging Solutions Tests

Packaging Solutions Tests

How do MDR changes affect your packaging approvals?

It can be difficult to understand the changes implemented as part of the Medical Device Regulation (MDR) updates for packaging validations. EUROLABhas a team of experts to help manufacturers bring currently approved packaging systems into compliance with the new requirements and provide test plans for new sterile barrier systems built to standards.

Packaging Solutions Tests

Adding 'packaging' and other packaging-related terms to the MDR requirements may seem simple, but the new language has important implications for device manufacturers: it means a regulatory review as manufacturers need to have data on justification and current results and the integrity of the sterile barrier.

MDR focuses on the entire life cycle of the device, emphasizing the importance of the package protecting the sterile barrier from production to point of use. In the evaluation of the packaging system, data must be found that successfully challenge the packaging system from distribution and use to the specified product expiry date.

The regulation states that “… devices labeled as sterile will be handled, manufactured, packaged and sterilized using appropriate validated methods”. The key implications here are that manufacturers use recognized test methods listed in harmonized standards to demonstrate the suitability of the packaging as a sterile barrier system. This change is evident when looking at the qualification process that notified bodies must meet to evaluate devices for market sales. Providing “specific qualification criteria for evaluation of the packaging” was determined as the main goal when making on-site device manufacturer visits.

Our team can evaluate changes in legal standards followed by previous tests against the most current legal standards, including:


  • Review of every standard followed by previous tests and new regulations that may now apply to instrument packaging
  • Review of final test reports made before
  • Any test suggestions needed to bring your packaging to the most up-to-date standards


Producers EUROLABThey leverage testing plans and processes established in . As part of our process, we perform validation testing using a focused lifecycle approach.

  • Test Plans  - We create test plans that take into account the design and validation of the packaging throughout its life. We start by evaluating packaging design, assessing sterilization compatibility, and determining expiration dates.
  • Deployment Hazards  Documented evidence of the transport environment, including temperature travel studies, demonstrates compliance to ensure the packaging will protect your product up to the aseptic point of presentation in the field.
  • Microbial Barrier Contamination Prevention  - We offer a complete range of microbial barrier tests to complete most packaging configurations, including flexible and rigid containers.

Understanding these new regulations and preparing to meet them is no small undertaking. Because EUROLABThe expert consultants at are ready to help you understand your testing needs and get your products certified and safe to the patients who need them.

EUROLAB, with its highly expert team and internationally accredited laboratories, Packaging Solutions Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.