Packaging and transport validation of medical devices
Why it is essential from a regulatory perspective – and how manufacturers can implement it in practice
The packaging of a medical device or an in vitro diagnostic device is far more than just a simple container – it is an integral part of the product and plays a key role in ensuring its safety and performance – right up until it reaches the user. Accordingly, packaging and transport validation is an integral part of the technical documentation under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2027/746 (IVDR). In this article, we explain the purpose of packaging and transport validation, the differences between sterile and non-sterile products, and what manufacturers should pay particular attention to from a regulatory perspective.
The aim of packaging validation
The aim of packaging and transport validation is to demonstrate that a packaging system protects a medical device throughout its entire life cycle – from manufacture through to transport, storage and use.
In the context of the MDR, packaging validation serves in particular to meet the requirements set out in Annex I (GSPR), including:
- Protection against mechanical and environmental influences during transport and storage (GSPR 7)
- Maintenance of the defined microbial status by the packaging (GSPR 11.3)
- Maintenance of the medical device’s sterility up to the point of use (GSPR 11.4)
- Use of validated packaging and sterilisation processes (GSPR 11.5)
- Packaging for non-sterile products must maintain the purity of the product and ensure the packaging system is suitable for the sterilisation process (GSPR 11.7)
In the context of the IVDR, packaging validation serves in particular to meet the requirements set out in Annex I (GSPR), including:
- Protection of the product against damage, contamination and impairment of performance during transport, storage and handling (GSPR 10.2)
- Ensuring that sterile or microbiologically controlled products retain their defined status until use (GSPR 11.1–11.3 and 20.3, where applicable)
- Ensuring that non-sterile products retain their integrity and purity (GSPR 11.5)
Packaging and transport validation is therefore not an optional formality, but a regulatory requirement for demonstrating product conformity. These requirements apply not only to sterile products, but in principle to all medical devices – including in vitro diagnostic medical devices – where packaging and transport have an impact on product quality and performance.
Regulatory framework: ISO 11607 as a global benchmark
The key series of standards for the packaging of sterile medical devices is ISO 11607, which is harmonised in the EU as EN ISO 11607-1 and -2 under the MDR and is recognised by the FDA as the authoritative state of the art for the validation of packaging systems for sterile medical devices.
- DIN EN ISO 11607-1: Requirements for materials, sterile barrier systems and packaging systems
- DIN EN ISO 11607-2: Validation requirements for forming, sealing and assembly processes
- prEN ISO 11607-3: Requirements for the process development of forming, sealing and assembly
- ISO 13485 (Validation of special processes)
- ISO 14971 (Risk management)
- ISO 62366‑1 (Usability during use, transport, storage and disposal)In addition, other standards apply, including:
For transport and storage validations, recognised standards and test specifications such as ISTA protocols, ASTM standards (e.g. ASTM D4169, ASTM F1929 or ASTM F2096) and product-specific regulatory guidelines are used, depending on the product, packaging system and distribution channel. Test methods are selected on a risk-based basis, taking into account the intended transport, storage and usage conditions.
Sterile vs. non-sterile medical devices: What are the differences?
Not every medical device places the same demands on its packaging. The decisive factor is whether the product is placed on the market in a sterile state.
Sterile medical devices
For sterile products, the primary packaging acts as a Sterile Barrier System (SBS). It must:
- ensure sterility right up to the point of use
- be capable of being opened aseptically (the packaging must be opened in a germ-free manner)
- be suitable for the sterilisation process
The validation requirements are correspondingly high: material qualification, leak and seal integrity tests, ageing and transport tests, as well as process validation of the sealing process (IQ/OQ/PQ).
Non-sterile medical devices
Non-sterile products do not require a sterile barrier, but must also:
- be protected against damage and contamination
- retain their function and quality during transport and storage
A risk-based assessment is also required for non-sterile products to ensure that packaging and transport do not compromise product performance and quality. The focus here is typically on transport and climatic tests. Formal process validation in accordance with ISO 11607-2 is usually not required, provided there is no sterile barrier system in place.
However, please note that the ISO 11607 series is certainly relevant for medical devices that must be reprocessed before their next use, as it addresses, amongst other things, the following:
- 17 Reusable containers – dimensionally stable sterile barrier systems (3.23) designed for repeated use
- 1.10 For reusable sterile barrier systems, e.g. containers and sterilisation pouches made of textile fabric, it must be determined whether reprocessing in accordance with the supplied instructions will result in damage that will impair the service life […]
- 1.11 In addition to the requirements in 5.1.1 to 5.1.7 and 5.1.10, reusable containers must meet the following requirements. […]
Appropriate validation must therefore also be considered for reprocessable products placed on the market in a non-sterile state, in accordance with the ISO 11607 series.
Expectations of Notified Bodies – and common errors
During audits and conformity assessments, Notified Bodies pay particular attention to the clear link between packaging and transport validation, GSPR and risk management. Of particular relevance are complete evidence of the stated shelf life, up-to-date standards, and a traceably documented change management process. Furthermore, it is expected that the selection of the packaging test specimen and the scope of testing will be justified on a risk-based basis, and that the validation evidence will cover the worst-case scenario for the respective packaging system and its transport routes and modes.
Common shortcomings among manufacturers include the fact that packaging is not taken into account until very late in the development process, that revalidation following a change of material or supplier is not carried out, and that the labelling of sterile and non-sterile variants is ambiguous. In the case of non-sterile products, packaging or transport validation is often completely absent, as manufacturers do not feel that the ISO 11607 series applies to them and there is no direct ISO equivalent for non-sterile products.
Phases of packaging validation according to ISO 11607
Packaging validation is not a one-off piece of evidence, but a process that accompanies the entire product lifecycle. The requirements of the ISO 11607 series range from the development of the packaging system, through the performance of validation activities, to the monitoring of packaging processes in mass production and the management of changes. The guide DIN CEN ISO/TS 16775:2022-04 provides a good overview of the processes.
1) Design and development phase
The performance and stability requirements set out in ISO 11607-1 must be taken into account right from the design stage of the packaging system. During the development phase, the intended sterilisation method, transport and storage conditions, and the target shelf life are specified, amongst other things. In addition, the requirements for the forming, assembly and sealing processes must be defined in accordance with ISO 11607-2.
2) Performance testing (validation phase)
The validation phase comprises three main sections, the first of which is the demonstration of the packaging’s performance and stability. Typical tests carried out as part of packaging validation include seal strength and leak tests, transport and drop tests, and accelerated and real-time ageing studies. For this purpose, requirements and test methods from ISO 11607, as well as relevant ASTM standards, are used, amongst others.
Annex B of ISO 11607-1 provides an overview of available test methods and their suitability. When selecting test methods, preference should be given in particular to those for which information on precision and systematic errors is available. However, as the standard does not specify a universally applicable procedure for the design of transport tests, established transport test concepts such as the ISTA protocols may be used as a supplement, for example the ISTA 2A procedure. This test concept is, incidentally, also highly suitable for non-sterile products.
Subsequently, a documented assessment of usability must be carried out to demonstrate that the medical device can be safely and aseptically removed from the sterile barrier system. If the requirements of ISO 11607-1, Section 7, are not met, the sterile barrier system must be adapted or redesigned accordingly.
Finally, the relevant characteristics of the packaging system must be validated. These include, in particular, verification of the microbial barrier properties, the suitability and compatibility of the packaging system for the intended sterilisation process, the requirements for labelling and traceability, and the control of storage and transport conditions for packaging materials and pre-fabricated sterile barrier systems. The aim is to demonstrate that the packaging system reliably fulfils its intended function throughout the entire product life cycle.
3) Production phase
Once the development and validation phases have been completed, packaging processes must be controlled and monitored under routine conditions. Critical process parameters must be maintained within the validated limits and documented regularly. Sterile barrier systems must be assembled under suitable environmental conditions to minimise the risk of contamination and ensure the efficacy of the intended sterilisation process. For reusable sterile barrier systems, the specifications for assembly, maintenance, repair and storage must also be taken into account.
Changes to packaging design, materials, processes or equipment must be assessed as part of a documented change management process. Where the integrity, stability or performance of the packaging system may be affected, a risk-based revalidation is required. This is the only way to ensure that the validated packaging system retains its protective function throughout the entire product life cycle.
Conclusion: Packaging and transport validation as a key success factor for manufacturers
Packaging and transport validation is not a peripheral issue, but a central component of regulatory compliance for medical devices. A transparently validated packaging system is crucial for ensuring product protection and safety, as
well as guaranteeing market access and auditability throughout the entire product life cycle – whether sterile or non-sterile. And thus ensuring that the product reaches the patient intact.
At the same time, sustainability considerations are also becoming increasingly important. With the European Packaging and Packaging Waste Regulation (PPWR), manufacturers will in future be under greater pressure to assess packaging systems not only in terms of safety and performance, but also with regard to material use, recyclability and resource efficiency. The challenge will lie in reconciling the requirements of the PPWR with the regulatory requirements for product protection, sterility and performance.
Manufacturers who take a holistic approach to their packaging, risk management, validation and sustainability requirements at an early stage can reduce regulatory risks, avoid rework and benefit in the long term from more robust and future-proof packaging concepts.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
