Medical device packaging must adhere to strict regulations for materials, sterility, and durability. Packaging that comes in direct contact with devices often falls under the same regulations as the medical equipment enclosed. Following established standards and industry best practices ensures compliance.
Medical Device Packaging Regulations
Some of these practices fall under established regulations. Medical device packaging regulations vary depending on where your products are used. For example, in the United States, the Food & Drug Administration establishes rules while the European Union’s Falsified Medicines Directive covers products for European distribution.
Food & Drug Administration Regulations
The FDA's Current Good Manufacturing Practice Regulations fall under Quality System regulation 21 CFR Part 820. Section 820.160 of the FDA’s regulations covers best practices for device manufacturers.
The FDA considers packaging to be part of the medical device and it must meet all requirements established in Sec. 820.160. Subpart K specifically addresses packaging and labeling requirements. Additionally, Sec. 820-160 clearly covers packaging from third-party packaging manufacturers.
“the manufacturer must define the performance characteristics, safety and reliability requirements, environmental requirements and limitations, physical characteristics, applicable standards and regulatory requirements, and labeling and packaging requirements, among other things, and refine the design requirements as verification and validation results are established.” — FDA Guidance on Best Practices for Medical Device Manufacturers
European Union Medical Device Packaging Regulations
The EU MDR aims to ensure that all medical devices are safe for users. It establishes requirements for repackaging of devices. Regulation (EU) 2017/745 of the European Parliament covers packaging design and suitability for sterile devices. Manufacturing processes and procedures must meet all requirements under this regulation.
ISO Standards
The International Organization for Standardization establishes standards and best practices for manufacturing. ISO 11607 applies to terminally sterilized medical devices. It features two main components.
- ISO 11607-1 includes medical device packaging design, materials, and testing methods. It is designed to minimize the risk of outside contamination reaching a sealed product.
- ISO 11607-2 addresses the validation testing requirements for medical devices.
Combined, these two components establish best practices for sterile medical devices. They help to ensure the safety and integrity of packaged devices. However, they only apply to devices between the point of manufacture and initial use. Additionally, medical device packaging can also be subject to other regulations and standards.
ISO 13485:2016 establishes internationally recognized best practices for medical device manufacturers. It helps streamline processes and sets device manufacturers up to successfully meet current regulations.
There are plans to synchronize medical device packaging regulations in 21 CFR Part 820 and ISO 13485 to create a more uniform framework of guidance and standards.
Validation Testing
Validation testing ensures that medical device packaging is suitable in terms of sterility, support, and protection of the enclosed device. Proper validation allows device manufacturers to maintain compliance with appropriate standards and regulatory bodies.
Validation usually includes a series of tests of the structure and closure integrity of the packaging. It may involve environmental challenges that simulate real-world conditions devices and their packaging may encounter. These tests ensure that devices arrive sealed, intact, and sterile at their destination to support patient safety.
Types of Validation Testing
There are several different types of validation tests used on medical device packaging. They usually fall into one of three categories: environmental, distribution, and structural and sterile integrity.
Medical Device Validation Tests
- Accelerated aging
- Aerosol challenge
- Dry time
- Shelf life
- Sterilization efficacy
Some packaging may undergo physical testing including bacterial filtration efficiency, burst tests, dye migration, and seal peal. Custom tests may be necessary for special situations.
Considerations for Medical Device Packaging
Medical device packaging must meet minimum requirements for strength and durability, In some cases, it must ensure sterility of the enclosed devices. This is achieved through careful design, testing, and manufacturing according to best practices.
Material Selection
At Ready-Made, we use sustainable materials for medical device packaging whenever possible. We most frequently manufacture trays in recycled HIPS. It is lightweight, durable, and easily formable. Recycled HIPS is a cost-effective and environmentally friendly option that meets a wide range of packaging needs in the medical device industry.
However, we can also use other materials depending on your specific needs. Each material has characteristics that might make it a suitable choice for packaging and shipping medical devices.
Medical Device Packaging Materials
- Virgin High-Impact Polystyrene: We can use virgin HIPS for a cost-effective packaging solution. It is lightweight, durable, and forms well for a variety of shapes.
- Recycled Polyethylene Terephthalate: RPET is made from recycled PET plastics. It is lightweight, durable, and environmentally friendly.
- Recycled Polyethylene Terephthalate ESD: RPET ESD has the same qualities as standard RPET, but it also helps dissipate electrostatic discharges to protect sensitive electronics on medical devices.
The most common material for our plastic medical trays is recycled HIPS. This is an affordable and environmentally friendly material.
We offer a fast turnaround time on trays in our stock materials, with many orders delivered within two weeks. We can usually source other medical-grade materials within a few weeks for custom trays delivered to you in about six weeks.
Design Inputs
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Packaging designs must be consistent with the intended product use. This includes the physical characteristics of the packaging and its suitability for the intended use. Design characteristics you should consider include:
- Size
- Material thickness
- Openings (size, shape, number)
- Sterility
You may need several different types of packaging for similar devices. Additionally, depending on the type of medical device involved, the design may need prior approval as part of the pre-market assessment.
Stock and Custom Medical Device Packaging
At Ready-Made Plastic Trays, we manufacture high-quality packaging for medical devices and instruments, implants, parts, and pharmaceutical bottles using industry-accepted best practices. Our trays meet requirements for sterility and security, ensuring your devices get to end users ready to use. Contact us to learn more or request a free sample.
