Medical devices – What information is to be supplied by the manufacturer?
As we are very much aware that the ISO 20417:2021 standard is already in town, Elexes Team has detailed in this article the need for the new labeling standard, ISO 20417:2021, which entails the information to be supplied by the manufacturers for a medical device or by the manufacturer for a medical device accessory. The primary reason behind introducing this standard was to present the accompanying information with the medical device in a clear manner so as to make the manufacturers understand the requirements in an unambiguous way. The ISO 20417 standard repeals its grandfather standard i.e the ISO 1041:2008.
Let’s look at the major differences between ISO 1041 and ISO 20417 now.
What is the main distinction between EN ISO 1041 and ISO 20417?
Though both ISO 1041 and ISO 20417 talk about the information to be supplied by the manufacturer along with the device, however, the ISO 20417 standard offers more clarity on the requirements, being in compliance with the current regulations at the same time. The ISO 1041 standard was drafted with keeping the MDD regulation in mind, however, ISO 20417 is in compliance with the current MDR and IMDRF regulations.
As opposed to the ISO 1041 standard, the ISO 20417 standard is more exhaustive and provides in more detail the information on “Legibility of Label” and “Durability of Markings”. Also, ISO 20417 provides a detailed view of the terms and definitions. For example, the MDR regulation uses the term Label and Labelling interchangeably which creates confusion in the reader’s mind, as “Labeling” is considered to be different from “Label” in other regulations. The ISO 20417 standard uses only the term “accompanying information” throughout the standard and specifically uses different terms as applicable to the context of discussion and requirements.
What are the new ISO 20417:2021 regulations for the labeling of medical devices and accessories?
- Use of Symbols
The MDR regulation does not clearly mention the use of symbols on a medical device label, causing confusion in the reader’s mind on whether to use the symbols or not. ISO 20417, on the other hand, specifies that information on labels can be provided in either text or symbol form. Also, ISO 20417 cross-refers to the ISO 15223 standard for making use of appropriate symbols on the medical device label. Symbols are often used to create concise labels and reduce the burden of translation when marketing a medical device in countries worldwide.
- Location of the Label
The MDR regulation does not provide clarity on the location of the label i.e whether it should be on the package or on the device itself. However, the ISO 20417 standard explicitly mentions under which conditions (such as the following) the label shall not be on the device:
- A label is not possible due to the device’s size
- The device’s surface material prevents the application of a label
- The lack of information on the device does not pose any dangers
There is additional guidance within the standard which states the information to be included within the Instructions For Use (IFU). The guidance states that only information required by legislation and information a user requires to safely and efficiently operate the device should be included in the instructions for use. All the information apart from this shall be left out, though it may be included in the technical documentation.
What is the best way to get from ISO 1041 to ISO 20417?
Don’t Worry! Elexes team is here to help. Our team has years of experience performing a gap analysis of the newly released standards and helping comply with them. Please contact us via email at email@example.com or call +1 650-503-6615 for further details.
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Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.