(Download: Shelf-Life Studies in PDF by Medistri)
Medical devices placed on the market with an expiration date must demonstrate, through documented evidence, that their safety, performance, and integrity are maintained throughout their intended shelf life. Shelf-life studies are a critical component of a manufacturer's technical documentation and regulatory submissions, under both EU MDR and FDA frameworks, and serve as the evidentiary foundation for the expiration dates printed on every device label.
This article provides a structured overview of shelf-life study methodologies, applicable normative standards, packaging integrity requirements, and the operational infrastructure required to execute these studies in a compliant and audit-ready manner.
1. Defining Shelf Life and Its Regulatory Context
Shelf life refers to the period during which a medical device is expected to retain its specified characteristics under defined storage conditions, prior to use. It is critical to distinguish this concept from useful life, which describes the operational duration or number of uses once a device has been placed into service.
The United States Pharmacopeia defines shelf life as “the extent to which a product retains, within specified limits and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of manufacture.” This definition underpins both FDA and EU MDR expectations for product stability and labeling accuracy.
Regulatory bodies, including FDA and the European competent authorities, expect manufacturers to provide objective evidence supporting shelf-life claims. Under EU MDR Annex II and III, shelf-life data must be incorporated into technical documentation and justify any expiration date on the label. FDA 510(k) submissions and PMA applications similarly require stability data as part of the performance testing record.
2. Defining the Right Shelf-Life Study Strategy
Establishing an appropriate shelf-life study is a structured and multidisciplinary process. Prior to testing, manufacturers must define several critical parameters:
- The intended shelf-life claim (e.g., 2 years, 5 years)
- Storage and distribution conditions (temperature, humidity, light exposure)
- Critical product characteristics and performance endpointsPackaging system configuration and sterile barrier architecture
- Applicable regulatory and normative standards (ISO, ASTM, FDA guidance)
Performance endpoints commonly evaluated include sterile barrier integrity, material stability, functional performance (e.g., connector pull strength, seal integrity), dimensional stability, and chemical compatibility. Test method selection must align with device design, packaging configuration, and the regulatory expectations of each target market.
3. Accelerated Aging Studies
Accelerated aging is widely used to generate shelf-life data within reduced timeframes. By exposing products to elevated temperature and controlled relative humidity, these studies simulate the natural aging process and allow manufacturers to project long-term performance without waiting for the full real-time duration.
Accelerated aging protocols are typically conducted in accordance with ASTM F1908, which provides guidance on the scientific basis and application of accelerated aging for medical device packaging. The Arrhenius model is commonly applied, using a Q10 factor of 2.0 as the default thermal acceleration coefficient, though alternative values may be justified based on material characteristics.
Accelerated aging studies are the primary mechanism for achieving early market entry while providing a robust scientific justification for shelf-life labeling. They are also essential for product line extensions, packaging changes, and post-market design modifications requiring revalidation.
4. Real-Time Aging Studies
While accelerated aging supports early submission and market access, real-time aging studies remain the definitive confirmation of shelf-life claims. These studies evaluate product stability under defined storage conditions over the actual intended shelf-life duration and are conducted in parallel with, or subsequent to, accelerated protocols.
Real-time data fulfills several important functions: it confirms the assumptions of the accelerated aging model, supports long-term lifecycle management, and strengthens regulatory confidence during routine production oversight and post-market surveillance. Some regulatory pathways and notified body expectations may require real-time data before full approval or CE marking is granted.
A comprehensive shelf-life strategy therefore integrates both approaches: accelerated aging to support initial submissions and real-time aging to confirm, archive, and sustain the claim through the product's commercial lifecycle.
5. Packaging Integrity and Regulatory Alignment
For terminally sterilized medical devices, shelf-life validation is inseparable from packaging performance. The sterile barrier system must demonstrate its ability to maintain sterility and physical integrity from the point of sterilization through the end of shelf life and until the point of use.
This performance obligation is governed by two complementary international standards:
- ISO 11607-1: Defines requirements and test methods for sterile barrier systems, protective packaging, and packaging materials
- ISO 116072: Addresses the validation requirements for forming, sealing, and assembly processes of sterile barrier systems
Sterile Barrier Integrity Testing (SBIT) is a core component of the post-aging evaluation process. Following environmental conditioning, test samples undergo laboratory evaluation using validated methods including dye penetration (ASTM F1929), bubble emission (ASTM F2096), visual inspection, and seal strength testing (ASTM F88). These methods generate objective evidence that the packaging system has not been compromised by the aging cycle.
Environmental conditioning, simulating distribution and handling stresses, is typically conducted in accordance with ASTM D4169 or ISTA 2A, ensuring that packaging performance is evaluated under realistic logistics conditions rather than static laboratory scenarios alone.
6. Shelf-Life Studies as Part of the Regulatory Go-to-Market Pathway
Shelf-life data directly supports a broad set of regulatory and quality deliverables. Well-executed studies contribute to:
- Design History Files (DHF) under FDA 21 CFR Part 820
- Technical Documentation required under EU MDR Annex II
- FDA 510(k) and PMA performance testing sections
- Product labeling with justified expiration dates
- Post-market surveillance data and complaint defense records
When properly integrated into the product development and validation lifecycle, shelf-life studies reduce regulatory risk, prevent adverse health outcomes linked to compromised or expired devices, and support consistent product quality from initial market entry through product sunset.
7. Shelf-Life Testing at Medistri: Infrastructure and Integrated Services
Medistri approaches shelf-life studies as an integral component of product industrialization and regulatory readiness—not as a standalone testing service. Operating across two accredited sites in Switzerland (Biel/Bienne) and Hungary (Debrecen), Medistri combines sterilization expertise with laboratory capabilities to support manufacturers throughout the study lifecycle.
Accelerated and Real-Time Aging
Controlled aging chambers at both sites provide validated temperature and humidity conditions required for accelerated aging protocols per ASTM F1908. Real-time studies are conducted under defined ambient conditions and monitored through formal study management systems, ensuring continuity and data integrity for multi-year programs.
Sterile Barrier Integrity Testing (SBIT)
Post-aging evaluation includes a full range of sterile barrier integrity and packaging performance tests conducted within Medistri’s ISO/IEC 17025-accredited laboratory. Methods are validated and traceable, supporting both internal study records and external regulatory submissions. Testing is performed by qualified technicians following documented procedures aligned to relevant ASTM standards.
Environmental Conditioning and Distribution Simulation
Distribution simulation testing (ASTM D4169, ISTA 2A) is integrated into the shelf-life study workflow, allowing manufacturers to evaluate packaging performance under both static aging and dynamic logistics stress conditions. This integrated approach reduces coordination overhead and supports a single, cohesive validation record.
Dual-Site Capacity and Supply Chain Resilience
Medistri’s dual-site infrastructure in Switzerland and Hungary provides geographic redundancy and capacity flexibility for multi-site shelf-life programs. Manufacturers with EU and US market obligations can consolidate study management while maintaining proximity to their sterilization and production operations. Both sites operate under harmonized quality systems, ensuring consistency of data across the program.
Learn more about Medistri’s Shelf-Life Studies by visiting our website here or contacting our team directly at contact@medistri.swiss.
— The Medistri Team
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Medistri Solutions for Products in Go-to-Market Phase
In the go-to-market phase, precision and speed are critical to demonstrate regulatory readiness, secure market access, and launch with confidence.
Medistri acts as your trusted, fully integrated infrastructure partner, providing a comprehensive suite of in-house Solutions tailored to support validation, submission, and commercial readiness.
Our solutions include packaging validation, shelf-life studies, cleaning & reprocessing validation, sterilization validation, custom cycle development, laboratory method validation, support-to-submission services, post-validation training, EO-free supply chain validation, CE Mark pathway consulting, and MDR transition consulting.
By managing the entire validation and compliance process under one roof in our Swiss facility, Medistri eliminates multi-vendor complexity, accelerates regulatory timelines, ensures consistent data quality and traceability, and allows your team to focus on strategic market entry and commercial execution.
Enabling a smooth, compliant transition from development to successful product launch.
Frequently Asked Questions
1. What is the difference between accelerated aging and real-time aging for medical device shelf-life studies?
Accelerated aging uses elevated temperature and controlled humidity to simulate long-term product aging in a compressed timeframe, allowing manufacturers to support early regulatory submissions and market entry. Real-time aging evaluates product stability under actual defined storage conditions over the full intended shelf-life duration. Both are scientifically complementary: accelerated aging generates predictive data rapidly, while real-time aging confirms those predictions and is required for long-term lifecycle management and sustained regulatory compliance.
2. Which standards govern shelf-life and packaging performance for terminally sterilized medical devices?
The primary standards are ISO 11607-1 (requirements for sterile barrier systems and packaging materials) and ISO 11607-2 (validation of forming, sealing, and assembly processes). Accelerated aging protocols are guided by ASTM F1908. Sterile barrier integrity test methods reference ASTM F1929 (dye penetration) and ASTM F2096 (bubble emission), among others. Distribution simulation typically references ASTM D4169 or ISTA 2A. Manufacturers must also align with applicable regulatory guidance, including FDA guidance on packaging validation and EU MDR Annex II technical documentation requirements.
3. How does sterile barrier integrity testing integrate into a shelf-life study program?
Sterile Barrier Integrity Testing (SBIT) is performed on aged samples at designated study intervals following environmental conditioning. It evaluates whether the packaging system has maintained its protective function despite the cumulative effects of aging, storage, and distribution stress. SBIT results, combined with seal strength and visual inspection data, constitute the objective evidence required to support expiration date labeling claims and ISO 11607-1 compliance.
4. What role does shelf-life data play in regulatory submissions under EU MDR and FDA frameworks?
Under EU MDR, shelf-life data is a required element of technical documentation (Annex II and III) and must substantiate any expiration date on the label. For FDA submissions, shelf-life validation supports the performance testing and packaging sections of 510(k) notifications and PMA applications. In both jurisdictions, the data must be traceable, generated using validated methods, and retained as part of the Device History Record or equivalent quality records throughout the product's commercial lifecycle.
5. Can shelf-life studies be conducted in parallel with sterilization validation?
Yes, and it is generally recommended from a project management perspective. Accelerated aging studies can be initiated with pre-sterilized samples as soon as the packaging configuration and sterilization process are defined, even before formal sterilization validation is complete. This parallel execution reduces overall development timelines. However, the final shelf-life claim must ultimately be supported by samples processed under the validated sterilization conditions and packaging configuration, ensuring that the study samples are representative of the commercial product.