When it comes to medical device packaging validations, one of the most common questions we hear is: “How often should we revisit our packaging validation to stay compliant?”
The answer? It depends.
Regulatory standards, product risk, material changes, and market dynamics all influence how frequently packaging validation should be reassessed. For example, a regulatory update may introduce new packaging integrity requirements, prompting revalidation. If a high-risk device is involved, more frequent assessments may be necessary to ensure patient safety. Changes in materials or suppliers could impact packaging performance, requiring compatibility testing. Additionally, shifts in market demand or distribution methods might introduce new environmental stressors that necessitate re-evaluation. In this post, we’ll explore the key factors that determine the timing of revalidation and provide a diagnostic tool to help you decide when to act.
Regulatory Expectations and Industry Standards
ISO 11607-1 and 11607-2, the global benchmarks for medical device packaging validations, require that packaging maintain its sterile barrier system throughout storage, transport, and handling. While these standards do not mandate a fixed revalidation schedule, regulators such as the FDA and notified bodies under the EU MDR expect manufacturers to provide ongoing evidence that their packaging remains effective.
Key compliance triggers include:
- Regulatory updates – If new guidance or revisions impact packaging validation requirements. For example, recent updates to EU MDR have introduced stricter requirements for packaging integrity testing, requiring some manufacturers to revisit and enhance their validation protocols.
- Audit findings – If a regulatory audit identifies deficiencies, identify and perform a gap analysis to verify you are completely covered.
- Customer complaints – If repeated issues arise related to packaging integrity or sterility.
When Should You Revalidate?
Packaging validations are typically not a one-time event—it’s a process that must be reviewed based on risk factors, operational changes, and evolving industry requirements.
Revalidation needs vary widely between companies and products—there is no one-size-fits-all approach. Factors such as regulatory changes, material updates, and product risk levels all influence when revalidation should occur. Use the Packaging Validation Diagnostic Tool below to determine whether you need to revisit your validation strategy.
Packaging Validation Diagnostic Tool
Answer the following questions to determine how often you should revisit your packaging validation:
Best Practices for Proactive Revalidation
- Establish a periodic review – Even in the absence of changes, review packaging validations at least every 3-5 years to stay ahead of compliance risks.
- Maintain thorough documentation – Keep detailed records of validation tests, complaints, and process changes.
- Engage cross-functional teams – Involve quality assurance, regulatory affairs, and packaging engineers in periodic reviews to ensure a comprehensive approach.
- Engage packaging experts – Partner with testing labs like LSO to ensure your packaging validation meets the latest regulatory expectations.
- Establish a periodic review – Even in the absence of changes, review packaging validation at least every 3-5 years to stay ahead of compliance risks.
- Maintain thorough documentation – Keep detailed records of validation tests, complaints, and process changes.
- Engage packaging experts – Partner with testing labs like LSO to ensure your packaging validation meets the latest regulatory expectations.
Conclusion
Revalidating medical device packaging is not just about compliance—it’s about ensuring patient safety and product integrity. By using this diagnostic tool and keeping up with industry changes, you can proactively determine when it’s time to reassess your packaging validation.
If you’re uncertain about your validation status or need expert guidance, reach out to LSO. We offer comprehensive packaging validation services, including integrity testing, accelerated aging studies, and regulatory compliance assessments to help ensure your medical device packaging remains fully compliant. Our team of packaging specialists can help you navigate the revalidation process and keep your medical device packaging fully compliant.
