Simply use symbols according to the current ISO 15223-1:2021? No, it’s not that simple. Annex I of the MDR/IVDR and other standards are also relevant for affixing the correct symbols and labelling. If you use the same labels internationally, you must always pay close attention to the status of the standards. And what is the difference between this and a safety sign? Let’s clear things up and give you an overview of the most important requirements for symbols, graphics and safety signs on medical devices and in-vitro diagnostics.
Why is it useful to put symbols on products?
At first attempt, one might tend to say at this point that yes, you MUST. And this is also correct. Within the framework of European Regulations 2017/745 MDR and 2017/746, Annex I, Chapter III, the legislator stipulates that the information provided by the manufacturer must be provided in the form of internationally recognized symbols, taking into account the intended users. “Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.” Irrespective of this legal requirement, there are also good reasons to use symbols: The symbols shown in ISO 15223-1 “Medical devices – Symbols for use in the information to be provided by the manufacturer” in particular are internationally recognised and ensure the same understanding of product characteristics and handling. Translation costs can be saved and translation errors avoided, and there is also more space on the product and in the warehouse, as fewer language variants need to be produced and kept in stock.
Regulatory knowledge on symbols
In Europe, as already mentioned, Annex I Chapter III of both regulations applies when it comes to symbols on medical devices. It should be emphasised once again that the symbols must comply with the harmonised standards for symbols, not can or should. The harmonised standard must therefore be applied here, and not an older or newer one. This is currently “EN ISO 15223-1:2021 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)”. However, things get interesting when other harmonised standards also specify symbols (or safety signs) that contradict those of EN ISO 15223-1. IEC 60601-1 is not yet harmonised under the MDR, but is an interesting example of this topic, which we will discuss in more detail in the next section.
However, it is also worth looking outside the EU when it comes to the regulatory requirements for symbols. For example, the Brazilian RDC 751/2022 also requires symbols for medical devices:
VI – The information may be presented in the form of symbols or colours that must comply with the applicable regulations or technical standards;
VII – If there is no regulation, the symbols and colours must be described in the operating instructions.
The Brazilian RDC 830/2023 for IVDs explicitly the use of ABNT NBR ISO 15223:
VII – The symbols on products intended for laypersons must be accompanied by a legend;
VIII – the use of other symbols not provided for in the ABNT NBR ISO 15223 standard is authorised on products intended for professional use, provided they are accompanied by a legend;
However, in addition to the respective national ISO15223-1 standard, other standards should also be taken into account, especially when it comes to additional symbols or the creation of your own symbols. These are as follows:
- ISO 15223-2: Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied – Part 2: Symbol development, selection and validationà currently under revision in the ISO Committee
- ISO 20417: Medical devices – Information to be supplied by the manufacturer
- ISO 7000: Graphical symbols for use on equipment
- ISO 7010 Graphical symbols – Safety colours and safety signs – Registered safety signs
- ISO 3864-1:2011 Graphical symbols – Safety colours and safety signs – Part 1: Design principles for safety signs and safety markings
The versions ISO 20417:2021, ISO 7000:2019 and ISO 7010:2019 are fully recognised as recognised standards by the American FDA. This is important because only symbols that have been developed by international standardisation bodies and recognised by the FDA do not have to be accompanied by an accompanying explanation, but should “only” be explained in the “Symbols Glossary”.
The difference between a symbol and a safety sign
Symbols are graphic representations on the labelling and/or accompanying documentation of a product that convey characteristic information without the supplier or recipient of the information having to master specific language skills.
Safety signs are signs that use colours, shapes and symbols to convey a particular safety message. The shape and colour of a safety sign must comply with ISO 7010.
Symbols communicate information at various points of contact with the medical device (e.g. during transport, storage, sale, use and disposal) and communicate residual risks relating to the medical device. In contrast, safety signs are used to communicate a warning, a prohibition or an instruction to minimise a risk. Their significance in risk minimisation is therefore higher than that of a symbol, but the minimisation effect must also be well documented.
If the symbols of EN ISO 15223-1 are combined with the specifications of ISO 7010, a symbol can also become a safety sign, although it is not standardised as such.
However, the decision-making process becomes more difficult if two, three or even four symbols/safety signs exist for one topic. In this case, the choice should be made carefully and justified:
The standard text of IEC 60601-1 section 7.2.3 “Inspection of the accompanying documents” should always be taken into account when making a selection:
When the MANUFACTURER uses consulting the ACCOMPANYING DOCUMENTS as a primary RISK CONTROL measure for a specific RISK […] and the USABILITY ENGINEERING PROCESS determines that marking the ME EQUIPMENT is required for the effectiveness of the RISK CONTROL, the ME EQUIPMENT shall be marked with the refer to instruction manual/booklet mandatory action SAFETY SIGN ISO 7010-M002 […]
Otherwise, symbol ISO 7000-1641 […] may be used to advise the OPERATOR of the location of the instructions for use or to consult the ACCOMPANYING DOCUMENTS.
This is an example of the risk-based consideration of when a symbol and when a safety sign can be used.
Which symbols have been added with the current version of EN ISO 15223-1:2021?
Below we would like to give you a brief overview of some new symbols available with the latest version of the standard. However, this list is not exhaustive. In any case, before claiming compliance with the MDR or IVDR, it is important to check that the symbols used are up-to-date and complete with the edition harmonised under the MDR / IVDR.
Typical questions around the topic of symbols
How can I ensure that all the required symbols and information are affixed to the medical device?
MDR Annex I, Chapter III describes requirements for labelling and instructions for use, Section 23.2 lists the requirements for labelling and Section 23.3. information on sterile packaging.
Further requirements for information to be provided by the manufacturer are set out in DIN EN ISO 20417. Depending on the product, there are product-specific standards that also place certain requirements on labelling, so manufacturers are asked to deal with the requirements in detail. The creation of a labelling checklist mapping information with relevant symbols can provide assistance here. It is advisable to include a risk analysis and a risk expert in the planning and selection of the symbols, as important safety information is recorded in the risk analysis.
If the medical devices are intended for the US market, considering the FDA requirements 21 CFR Part 801 as well as further detailed guidance and product requirements is required.
Where should the required symbols and information be affixed?
Labelling refers to a label or direct marking on the medical device and its packaging as well as the instructions for use and other information provided by the manufacturer for users and/or patients. Labelling includes written and graphic information, whereby the meaning of the graphic information must be explained.
How do I ensure that the information provided is read and understood?
DIN EN ISO 20417 requires that the information to be provided by the manufacturer must be written and presented in terms that are easily understood by the intended users. In other words, manufacturers need to think carefully about who the user is, a layperson or a user with specialised medical knowledge? By using standardised symbols in labelling, manufacturers can effectively communicate important information to users and reduce the risk of errors or misunderstandings. However, users may not be immediately familiar with all symbols, so it is important to explain any graphic information that replaces text, such as pictograms, symbols, safety signs and safety-related identification colours.
What font size must the information be in?
A noble wish, but one that cannot simply be answered with “Yes, take a size 6”.
In Australia, Essential Principle 13.1((5) stipulates a minimum height of one millimetre. The South Korean “Regulation on labelling and description of medical devices” stipulates a minimum font size of 6 (professional users) or 7 (products for laypersons).
In Europe and other MDSAP member countries such as Canada, however, no specific requirement is defined, but there are similar requirements that the size of the information must be chosen so that it is legible and understandable and remains available over the entire service life of the product, which is where risk management, usability and service life/packaging tests come into play.
When designing the information – i.e. labels and instructions for use – there is a lot of important content to consider and to be interlinked. In particular, in order to use symbols correctly and to benefit from their advantages, namely the possibility of saving space through fewer translations and thus enabling smaller packaging. But also, to communicate the correct use and to minimise incorrect application. We would be happy to support you in designing your MDR-compliant labelling!
Please note that all details and listings are not intended to be exhaustive, are without guarantee and are for information purposes only.