When it comes to medical equipment, safety and how well they work are the most important things. To ensure this, makers establish standards and rules to ensure that healthcare workers and patients receive clear and accurate information. EN 1041 stands out as one of these crucial standards, playing a key role in how manufacturers label medical devices. But ISO 20417:2021 took the place of EN 1041 when the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) came out.
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How and why it started:
The European Committee for Standardization (CEN) came up with EN 1041, which was a European standard. It was called “Medical Devices – Information Provided by the Manufacturer (Labelling)” in its full name. EN 1041’s main goal was to make sure that medical devices had accurate and complete labels with clear directions for how to use them safely and effectively.
Important parts of EN 1041:
- EN 1041 says what information must be on the stickers of medical devices. This information typically encompassed the device’s name, its intended purpose, usage instructions, manufacturer details, lot number, expiration date, and any specific storage guidelines.
Symbols and Pictograms
- The standard gave a set of symbols and pictograms to quickly communicate important information. This made sure that important directions and warnings got through.
User Manuals and Instructions on How to Use
- EN 1041 stressed how important it was to have complete user manuals and clear instructions on how to use the device in the language(s) of the countries where it was sold.
Concerns about EN 1041:
EN 1041 effectively fulfilled its intended purpose for an extended duration; however, over time, certain issues and constraints became evident. Some of the most important ones were:
Regulatory Landscape Changes
Regulations have changed a lot in the medical device business, especially since the new European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) came out. Initially, EN 1041 aligned with the MDD and IVDD; however, it necessitated updating to adhere to the more rigorous standards imposed by the MDR and IVDR.
Not having UDI Requirements
EN 1041 did not include the idea of Unique Device Identification (UDI), which became a key legal requirement under the MDR and IVDR. UDI provides a standardized method for identifying and monitoring medical devices throughout their complete lifecycle, enhancing their traceability and post-market monitoring capabilities.
With advancements in medical tools and devices, the requirement emerged to encompass additional elements such as accessories and in-vitro diagnostic medical devices. The initial scope of EN 1041 inadequately covered these elements.
The standard emphasized the necessity of formulating usage instructions for the device in the languages spoken within the countries of its distribution. However, this requirement posed challenges due to the European Union’s multilingual composition. Providing all the essential information in multiple languages proved particularly daunting for manufacturers, especially those operating on a smaller scale.
ISO 20417:2021 will take its place:
Due to the introduction of the new EU MDR and IVDR, there arose a necessity to revise and enhance medical equipment standards. As a result, ISO 20417:2021 eventually replaced EN 1041. This new standard outlines the labeling requirements for medical devices and accessories in accordance with the updated regulations.
ISO 20417:2021 and EN 1041 have some key differences:
EN 1041 was mostly about medical devices, while ISO 20417:2021 covers both medical devices and accessories, as well as in-vitro diagnostic medical devices.
ISO 20417:2021 incorporates standards for Unique Device Identification (UDI), which the EU MDR and IVDR now mandate for certain categories of medical devices.
Alignment with EU Regulations
ISO 20417:2021 has been developed to align with the standards set by the new EU MDR and IVDR, ensuring its compliance with the latest regulatory framework.
In conclusion, ISO 20417:2021 has proven to be a pivotal asset to the healthcare industry. It effectively tackles the limitations that were evident in its precursor, EN 1041. By establishing a precise and well-defined framework, ISO 20417:2021 eradicates any potential for assumptions. As the landscape of medical device regulations continues to evolve, this standard steps in to bridge the gaps that EN 1041 had left behind. Its primary focus is on upholding the utmost standards of safety, accuracy, and effectiveness in the labeling of medical equipment.