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Do you have to do usability engineering for sterile medical devices? We have looked at the current norms and standards to answer this question. Of course, we have selected and summarized the relevant passages for you. So you know exactly what is expected of you.
At the end of this article, you will find information on how you can pragmatically fulfill the requirements that the norms and standards place on you.
What does the MDR say about sterile medical devices?
The Medical Device Regulation (MDR) (EU) 2017/745 sets out requirements for medical devices, including sterile medical devices, in the European Union. The regulation aims to increase the safety level of medical devices and improve patient protection.
Sterile medical devices are covered by the MDR, and here are some of the relevant points regarding sterile medical devices:
- Definition and classification: The MDR defines and classifies medical devices. Sterile medical devices can be divided into different classes depending on their intended use and risk profile.
- Sterility requirements: Manufacturers must ensure that their products remain sterile throughout their intended use. This means that the packaging, storage and handling must be designed in such a way that sterility is guaranteed.
- Quality assurance: Manufacturers of sterile medical devices must have a quality management system in place to ensure that the products are manufactured in accordance with the requirements of the MDR.
- Technical documentation: Manufacturers must create and maintain comprehensive technical documentation for their devices, including information on design, manufacturing, sterilization procedures and validation, and clinical data.
- Traceability: The MDR requires comprehensive traceability of medical devices in order to be able to quickly identify the source and distribution channel of a product in the event of a problem.
- Post-market surveillance: Manufacturers are obliged to continuously monitor their products after market launch in order to identify and respond to any problems or safety concerns.
- Labeling and information: The MDR sets requirements for the labeling of medical devices, including information on sterility. The device must contain clear information on whether it is sterile and, if applicable, instructions for reprocessing.
This is just a brief overview of some of the requirements that the MDR places on sterile medical devices. Manufacturers, importers and distributors must carefully review the entire regulation to ensure that they meet all relevant requirements.
All usability requirements can be found in this article: “Deep Dive: MDR and Usability“. Here we have listed and explained all the points that affect the usability of your (sterile) medical device.
What does the FDA say about sterile medical devices?
The U.S. Food and Drug Administration (FDA) has extensive regulations and guidelines for sterile medical devices. They affect both the manufacture and the marketing authorization of these products. Here are some key points that the FDA has defined for sterile medical devices:
- Premarket Approval, PMA: Some sterile medical devices, especially those with a high risk, require pre-approval by the FDA. This process includes a comprehensive review of the safety and efficacy of the product.
- 510(k) notification: Many sterile medical devices enter the market via the 510(k) process. This requires the manufacturer to demonstrate that the new device is “substantially equivalent” to a device already on the market.
- Good Manufacturing Practice, GMP: The FDA has defined detailed GMP requirements for medical devices, including sterile products. These requirements apply to the entire product life cycle, from development to production and distribution.
- Sterilization procedures: The FDA provides specific requirements and guidance for various sterilization processes, such as ethylene oxide sterilization, radiation sterilization, and steam sterilization.
- Validation: Manufacturers must validate the sterilization process to ensure that the product is consistently sterile using the intended sterilization method. The FDA provides expectations and guidance for the validation of sterilization processes.
- Quality Control Systems: The FDA requires that manufacturers of medical devices, including sterile devices, implement and maintain quality control systems to ensure that their products consistently meet established quality standards.
- Traceability and reporting: Manufacturers must have systems in place to trace products and report problems or adverse reactions. This is particularly important for sterile products as sterility issues can have serious health consequences.
- Labeling and packaging: The FDA has specific requirements for the labeling and packaging of sterile medical devices. The labeling must contain clear instructions for use and storage as well as information on sterility and expiration date.
It is important to emphasize that this is only an overview of some of the FDA’s requirements and guidance for sterile medical devices. As a manufacturer, you must also fulfill additional requirements.
The DIN EN ISO 11607-1
DIN EN ISO 11607-1 relates to the packaging for medical devices to be sterilized in the final packaging. The standard specifies requirements and test methods for materials, sterile barrier systems and packaging systems intended to keep medical devices sterile during sterilization, to package them sterile and to keep them sterile until use.
The standard is divided into two parts:
DIN EN ISO 11607-1: This part specifies requirements for the materials, sterile barrier systems and packaging systems.
DIN EN ISO 11607-2: This part specifies validation requirements for the sealing processes.
When manufacturing, packaging or sterilizing medical devices, this standard may be relevant to ensure that the devices are sterilized safely and effectively and that their sterility is maintained until the time of use. It is important to note that standards can change over time, so it is always a good idea to consult the latest version of the standard and ensure that you meet the current requirements.
And what does DIN EN ISO 11607-1 say in relation to the usability of your sterile medical device? The following passages are relevant for you. You can find them all in chapter 7.
And what does DIN EN ISO 11607-1 say about the usability of sterile medical devices?
DIN EN ISO 11607-1, in particular chapters 7.1 to 7.5, specifies the requirements for the suitability for use of sterile barrier systems:
7.1: It must be demonstrated that the sterile contents can be removed aseptically from the sterile barrier system. This is done through documented usability tests.
7.2: The assessment of usability includes checking the recognizability of the start of opening, the comprehensibility and feasibility of the opening technique without contaminating or damaging the contents, and the possibility of subsequently providing the contents aseptically. Conditions of use, including personal protective equipment, should be taken into account. Avoiding contamination from external edges and minimizing exposure to harmful substances are essential.
7.3: The evaluation can take place under real or simulated conditions. A usability laboratory can be used for this purpose.
7.4: The assessment of usability can be adopted for product and packaging families based on worst case or other justifications. Data from predecessor products or similar products can be used.
7.5: If the assessment under 7.2 does not meet the criteria, the sterile barrier system can be redesigned or additional information can be provided. A new assessment is then required. Safety risks should be eliminated by improving usability.
The DIN standard makes a particularly important note on implementation:
“NOTE As part of (or prior to) the evaluation of suitability for use, it may be useful to conduct formative studies in which users are observed examining a sterile barrier system with its opening functions without outside assistance. It may also be beneficial to conduct summative studies on designs that may come to market, with the objective of observing whether individuals opening the package use the opening features as intended or whether they perform the opening and delivery in other ways. (For further information see FDA guidance  and IEC 62366 series of standards).” (Source: DIN EN ISO 11607-1; Chapter 7, Note)
Here, DIN EN ISO 11607-1 gives the clear recommendation to follow usability engineering according to IEC 62366-1 or human factors engineering according to the FDA Guideline.
We agree with the recommendation of DIN EN ISO 11607-1 and advise you to develop your product with usability engineering in accordance with IEC 62366-1. For a more in-depth introduction to the topic, take a look at our article: Usability engineering process according to IEC 62366-1.
The process helps you to meet all MDR usability requirements for your medical device as pragmatically as possible and to provide the necessary evidence for the notified body. The process is also FDA-compliant and therefore also an important part of obtaining approval in America.
Usability plays a crucial role in the world of medical devices, especially when it comes to sterile products. The regulations of the Medical Device Regulation (MDR) in the EU, the U.S. Food and Drug Administration (FDA) and the DIN EN ISO 11607-1 standard provide comprehensive framework conditions that manufacturers must observe.
The MDR emphasizes the need for a high level of safety and patient protection. This includes detailed requirements for sterility, quality assurance and comprehensive technical documentation. These regulations ensure that sterile medical devices remain safe and effective, from the manufacturer to the end user.
In the USA, the FDA also sets strict standards. With regulations such as pre-approval for high-risk products and detailed GMP requirements, the FDA aims to ensure the safety and effectiveness of sterile medical devices. The requirements for sterilization procedures and quality assurance are particularly important here.
The DIN EN ISO 11607-1 standard supplements these regulations with specific requirements for the packaging of medical devices to be sterilized in the final packaging. Among other things, it stipulates that manufacturers must carry out documented usability assessments. This includes checking whether the sterile contents can be removed aseptically and takes into account real or simulated conditions of use.
Finally, the application of usability engineering according to IEC 62366-1 is an important step to meet both MDR and FDA requirements. This approach helps to optimize the usability of sterile medical devices while providing a solid basis for market approval in different regions. Manufacturers who follow these guidelines contribute significantly to the safety and effectiveness of their products while meeting important regulatory requirements.
Do you need help with usability engineering for sterile medical devices or preparing your documentation for approval? Get in touch using our contact form. We will be happy to help you and look forward to hearing from you.