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Systematic Labeling for Medical Devices

October 2023 - Livia Keller 

Bachelor Thesis HSLU - Spring Semester 2023 

​In my thesis, I focused intensively on developing an innovative process and generic product requirements for the labeling of medical devices. Discover how my work helps to optimize and comply with labeling requirements for medical devices. Learn more about this exciting project in collaboration with ColabON AG.

Problem Statement: Labeling Medical Devices

Labeling is an integral part of a medical device. International standards and regulations impose a wide range of requirements for labeling medical devices. These requirements often include numerous redundancies, which have increased significantly in recent years.

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In the medical device industry, labeling medical devices creates numerous compliance challenges. High-quality labeling demands interdisciplinary collaboration across various departments within a company. However, responsibilities and interfaces between these departments are often not clearly defined. This results in interface issues, making it difficult to ensure traceability and accountability of labeling claims with respect to regulatory requirements.

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These challenges lead to significant document maintenance efforts (product care), increased compliance risks, and lower quality of labeling documents for medical devices. In the event of regulatory changes, these inefficiencies may even necessitate a complete overhaul of the labeling process.

Hypotheses: Optimized Labeling for Medical Devices

This thesis is based on the following hypotheses:

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  1. The application of a proposed systematic labeling process can significantly reduce the effort required for regulatory changes and product maintenance in medical devices.

  2. The initial quality of labeling documents can be improved by utilizing the proposed systematic labeling process approach.

  3. The proposed systematic labeling process can address the majority of requirements derived from applicable standards and regulations.

Key Questions

What are the challenges in labeling medical devices?

According to a survey conducted among participants from publicly listed companies and established SMEs, the industry faces the following major challenges in labeling medical devices:

  • Traceability of labeling requirements: From standards and regulations to implementation.

  • Systematic interpretation of standards: For consistent and efficient labeling practices.

  • Systematic creation of labeling specifications: To ensure clarity and compliance.

What standards and regulations must be considered?

For the EU, the following documents are essential for designing compliant labeling for medical devices:

  1. ISO 20417:2021: Replacing EN 1041, this standard specifies requirements for the labeling of medical devices, focusing on the presentation and accessibility of manufacturer-supplied information (labeling materials). Although not yet harmonized with MDR and IVDR, it is crucial for ensuring readability and understanding.

  2. MDR 2017/745: Defines the essential regulations for labeling materials, particularly outlined in Annex I, Chapter III.

  3. ISO 15223-1:2021: Specifies requirements for symbols used in labeling materials for medical devices. This harmonized standard replaces ISO 980 and ensures consistent symbol usage for better comprehension.

Solution Concept

The methodology of this bachelor project began with a survey to validate industry challenges. Simultaneously, a comprehensive list of applicable standards and regulations was compiled. These standards were then interpreted and evaluated with contributions from industry experts.

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The focus of the thesis was on EU requirements and the reduction of redundancies. Key references included ISO 20417:2021, MDR 2017/745, and ISO 15223-1:2021. The project collaborated with ColabON AG, which provides modular quality management system solutions and predefined medical device requirements through its application. This application was further enhanced through the outcomes of this thesis.

Results

Reduction of Redundancies

The creation of generic labeling requirements significantly minimized redundancies. This ensures that manufacturers can implement general labeling requirements efficiently and clearly, while allowing for the addition of modular, product-specific requirements. This improves the quality of labeling materials and enhances product safety.

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Enhanced Traceability and Efficiency

The proposed labeling process provides manufacturers with a systematic approach to implementing labeling materials accurately and on time while ensuring traceability. This allows manufacturers to verify and validate compliance with labeling requirements effectively. Seamless traceability reduces the maintenance effort for labeling documents.

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The Role of Quality Management Solutions

The use of quality management solutions, like those offered by ColabON, can drive transformative changes in the industry. Many manufacturers still rely on traditional methods, such as manual, one-to-one management of specific labeling documents for each product. These methods are extremely time-intensive, particularly when adapting to changes in standards and regulations.

By adopting advanced solutions, valuable time resources are freed up, allowing employees to focus on core tasks instead of the error-prone, manual maintenance of labeling documents.

 

Cost and Time Savings

Efficient solutions not only save time and labor but also lead to significant cost reductions. Automating compliance processes reduces the burden of implementing labeling changes and ensures swift adaptation to regulatory updates.

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Conclusion​​​

 

The systematic labeling process developed in this project lays the foundation for better traceability, higher-quality labeling materials, and reduced redundancy. With the integration of ColabON's quality management solutions, the industry can transition from outdated practices to efficient and scalable processes, ensuring compliance, saving costs, and enabling innovation in the labeling of medical devices.

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​#MedTech #ComplianceSolutions #MedicalDevices #ColabON #ISO20417 #ISO15223 #MDR #IVDR #MedicalTechnology #DataManagement #InnovationInMedTech #StandardsAndRegulations #DigitalCompliance #VersionControl #MedicalDeviceLabeling #IndustryCollaboration

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About me

  • I am Livia Keller, an enthusiastic young woman from the St. Gallen Rhine Valley.

  • After completing my Matura in Eastern Switzerland, I decided to take a leap and move to Central Switzerland to pursue a degree in Medical Technology at the Lucerne University of Applied Sciences and Arts, School of Engineering and Architecture. Alongside my studies, I seized the opportunity to work as an intern at ColabON AG. During this time, I gained valuable experience and deep insights into the world of medical technology, standards, and regulations.

  • In the summer of 2023, I successfully completed my bachelor’s thesis and graduated. I am now motivated to share my extensive knowledge and experience in this field, work on future projects, and expand my skills into new areas.

  • If you need more information or support in this area, please don’t hesitate to reach out to me. I am eager to assist you and look forward to achieving great things together!

Livia

Collaboration with ColabON

Bachelor's theses at the Lucerne University of Applied Sciences and Arts - School of Engineering and Architecture are always carried out in collaboration with an industry partner. In this case, the project was conducted in partnership with ColabON.
ColabON creates compliance solutions using a content-based and version-controlled database.

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