1. Introduction

The labeling of medical devices shall be a matter of crucial importance for the design, development, manufacturing and virtually every other phase of life cycle of medical devices, particularly during the operational period. However in real life, as one can see, manufacturers either do not duly care about label contents and description, or take every effort in order to conceal any related activities. For example, why is there usually little to no information regarding labels, their content and location, in the operating manual or in the IFU? Why is labeling information often omitted when it comes to the review of design or manufacturing workflow used by a particular manufacturer? Or when you read a Risk Management Analysis file for a medical device often the only available information on labeling is just the statement confirming that the label exists, but no details are available regarding any particular label-related risks (i.e. whether it is generally usable, clear, readable etc.).

Of course, we understand that we may be a bit too pessimistic with the approach outlined above. However let’s go deeper into the matter of labeling and clarify why it is necessary, and what kind of related information is required or at least desired. We`ll start, however, not from the top end, i.e., lists of requirements, standards and statutory orders, but rather take a look from the common user’s point of view and describe a usual, “regular” label we all are used to see on common devices (not necessarily medical ones) and in related documentation.

2. Identification of devices

One may suggest that the common user has zero knowledge regarding labeling requirements, i.e. knows nothing about the necessary content, related regulations or rules of description. This is largely true, but everybody can see dozens of labels in everyday life, so the common person has his/her own personal view regarding label content. So, if you take any common user and ask him/her to take a short survey and tell what, in their opinion, should be presented on the labels for particular products, you`d certainly be surprised, as common people will practically recite the major part of the regulatory or standard requirements, despite the obvious lack of specific knowledge (except the most basic understanding of the fact that there should be certain requirements or standards these days). But the common person had acquired this knowledge at the time of the “survey”, because he or she was able to see exactly the same information (or rather the same set of data) a thousand times already (ok, give or take a few times at least).

We can continue with this idea and with examples highlighting the importance of “customer focus”, “operational suitability” and other express or implied features or qualities. It is also quite probable that the end user will make a certain decision about the product, often assuming that a particular product has an advantage compared to otherwise similar goods, based on the fact whether certain information is stated or disclosed\indicated on the label by the manufacturer. This means that labels may constitute an important part of market competition strategy. But let`s turn back to the specific matter, namely to the information content of labels. Below we outline the scope of data that our common user expects to see on labels, along with the some comments and examples.

So, what is this commonly expected scope of the data? This includes the name of the product, i.e., the true and correct identification of the device, something similar to one’s full name stated in the passport, in general. In other words, it answers the question, what do we have here?

Further, is the name of the device itself always satisfactory for its identification? Or, rather, the question is: what shall comprise proper identification? Suppose the manufacturer makes several different models under the same brand name, then the exact name shall include certain clarifications (if any). Of course, most manufacturers do the correct thing, i.e. they state both the brand or trade name and model name. Or they provide the name and number (usually known as the REF number or something similar) to indicate the position of the device concerned in the company catalogue, etc. All three parameters may be indicated, too. And here we may return to the similarity we noted in the previous paragraph, i.e. to the full name in a person’s passport. One may state that it is not a good similarity since we may have dozens of people, citizens of the same country, hawing exactly the same full name. And here a lot of manufacturers could be brought into the bright light of criticism, as “true and correct identification” also means “full” and “final” identification. For example, the manufacturer provides devices in various color schemes, and does not indicate that fact either in the model name, or in the REF number, or by any other means. Probably the manufacturer does not see any good reason to do that. We just would not speculate about the end user’s feelings (and silent thoughts addressed to the manufacturer) when they are faced with two absolutely similar packagings with zero chance to determine (without opening the packaging) which one contains the devices with the necessary color scheme.

Well, with the exception of certain differences between goods produced specifically for children compared to those intended for the general population, one may say that the color scheme does not effect any usability features of the device. Then we have another example for you: sometimes the manufacturers imply certain design differences within the range of devices with the same model name, and sometimes the difference is such that the scope of application of the devices concerned may be different (changes may affect versatility, for example). In that case, unlike with the color scheme, the user simply cannot understand, based on appearance, which type of device is provided. And that is really unfortunate.

So, let`s finalise our vision on what is “true and correct identification”. The user, when reading the “full name” of the device, particularly on the label (which may include the name of the device, model, REF no. or similar reference and other parameters) generally shall not be concerned about any possible misinterpretation, nor shall they be forced to look for any distinctive features of the model (which may not be present on similar devices of the other model), etc. In other words, the identification information shall be sufficient and comprehensive. It is especially important when a decision should be taken quickly, i.e. in an emergency, when any delay or mistake may result in significant harm or an even worse outcome.

Now, let`s expand this “identification” term, adding some other parameters such as information about the manufacturer (its address, phone number, email, web address, etc.), which could be provided separately or all in one block. The manufacturer’s name serves not only for identification of the device (there is a small but still not quite zero chance that two different devices will have the same name, or the manufacturer will be the same but represented by different local branches), but it serves also as a source of information about the main entity that is responsible. This information is important for the end user, because the more known the name of the manufacturer is, the more trust it implies, and there are more reasons to assume the good quality of the device concerned. From the statistical point of view, there are virtually no issues with this matter, as the manufacturers always state some information of that kind. The source of the problem here is the validity of such information if it is amended, e.g. the correctness of the name of the manufacturer, its organisational form, address, etc. We did not highlight this specifically before, but it is clear that all supporting information related to the device, including its label, should be up to date. In the event of any changes, it shall be updated as soon as possible, with the highest priority.

An additional parameter related to the manufacturing information is the location of the production facility. When the manufacturer has several production facilities, or when the manufacturing facility is not located at the same address as the office, this shall be clearly stated on the label, because of possible liabilities, etc. (of course, we are not always thinking in such a dark way, but still it is a valid reason for knowing this information). For the end user, the location of the manufacturing facility also is important: the better the perception of certain business locations, the more trust the user puts in the device in question.

As for foreign manufacturers, the reasonable expectation of the end user is to see the information about the local office of the company (through legal implications and possible language barriers), or at least to see the address of the Authorised Representative for a particular region or group of countries. As an example, we can mention the well known EC REP (Representative in the European Community) line on the labels of medical devices distributed in the EC (you can be 100% sure to see that info when the manufacturer is not based in the EC or if there is a representative company acting on behalf of the manufacturer).

Another obvious piece of information to be included on any label is the lot number or batch number. It is necessary for the identification or tracing of a certain individual device or lot of the devices. For instance, when you have several similar devices in use, and this number helps to understand which device should undergo routine maintenance. It is not often, but still may be the case when the serial or lot number also bears certain information about the production facility, date of manufacturing, model, etc. Don`t forget the dates — this is the type of label info which usually catches the primary attention of the end user, namely the date of production (manufacturing date) and, if applicable, the “use by”’ date or any similar expiry related information. We will discuss this matter later in more detail.

Let`s have a look at a particular case of a multicomponent device (often it is also a reusable one). In this case, it is really important to put the date information on every component and state the name of the component on its individual label. Otherwise, usage of the device could be impeded, since the end user will need more time to study it, e.g. what is this particular component intended for, how it shall be applied or connected, etc.

And yet there is another particular instance, rather related to the supporting identification information for the manufacturer, product family or individual device: that is, trade marks. Labels often bear trade marks or signs, properly registered and therefore legally protected within a particular jurisdiction. The end user may often see this type of mark on the labels or on the packaging itself. Again, branding is the way to generate a certain level of trust in the device. But only a few end users may understand why we emphasise this part of the statement: “properly registered and therefore legally protected within a particular jurisdiction”. Often the manufacturer pays little attention to the fact that a trade mark should be legally protected within the jurisdiction of the device’s application or usage, otherwise registered trade marks and related information shall be removed from the label.

So, let`s summarise all the aforesaid in relation to the identification of the device via its label, and specifically related to the label content:

1. The name of the device concerned is mandatory for the purposes of identification.
2. The model, catalogue ref number, etc., are mandatory (if any) for the purposes of identification.
3. The manufacturer’s information is mandatory for the purposes of identification.
4. The production facility is mandatory (if any) for the purposes of identification.
5. Information about the Authorised Representative is mandatory (or recommended) for the purposes of identification of the person responsible for certain activities within the territory on which the devices in question are circulated.
6. The serial no., batch\lot no. are mandatory for the purposes of identification.
7. The name of the device component is mandatory for the purposes of identification of the individual components in multi-component and (usually) reusable devices.
8. The trade mark is to be placed voluntarily when there is proper registration in the country of circulation.

3.Usage of the device

Our next question to discuss is what usually has to be placed on the label in order to ensure proper operation or application of the device.

Firstly, most labels contain reference to the accompanying documentation such as operating guide, manual or IFU. This is to remind the end user that he/she has to refer to the accompanying documentation (and/or descriptions placed on the packaging, if any) which actually regulates all issues related to the usage of the device concerned, and to highlight the mandatory nature of this document (which means it shall be read through and understood before any usage or application of the device, and anything else is not acceptable). Jokes such as: “Reading the instructions is your last resort” or “You may read the instructions only when there are no other means to entertain yourself” are unacceptable, especially when the equipment is high risk, as is common for medical devices. The user shall be referred to the accompanying documentation (with the highlighted mandatory nature of reading it) as often as it can be considered practical, since people usually strongly dislike the very idea of reading such material.

Furthermore, the labeling usually contains important prohibitory or permissive signs or text stating the presence of a particular material (for end users with allergies), information on the restriction of reuse, information related to indoor/outdoor usage, information on combined usage with particular devices or equipment etc.

Here we would like to draw specific attention to an issue that is unfortunately frequent, and this is the lack of any proper description of the labeling, including label content and location. The end user may say (and this will be quite a justified statement): hey, I see the symbol but how about the description? Do I really have to guess about its meaning? Any situation in which the end user is not certain, has concerns or unanswered questions, undermines the safety and efficiency of the device concerned. This creates a risk of misuse. And usually there are no reasons not to include a detailed description of the label content.

Another important parameter to be stated on the label are dates and lengths of time, i.e. manufacturing date, shelf life or “best used before” date etc., combined in any possible way. For certain groups of devices (often reusable ones) it is predominantly the manufacturing date. For other types of devices, when it is critically important to state the “use by” term on the label (e.g. for single use sterile items) the main focus is the end date of the shelf life or “use by” date, since after its expiry the use of the device is strictly prohibited. There could be various combinations of such information on the label: the manufacturing date only (when the shelf life is stated in the IFU or operating manual), the manufacturing date and shelf life or useful life, or the manufacturing date and end date (BBD or “use by” date). The main purpose is nevertheless the accurate and simple identification of the manufacturing date and end of use for the medical device concerned.

Other important parameters to be stated on the label are various specific characteristics of the device, depending on its particular nature. For example, it may be the dimensions of the particular part, stated not just for appearance or for filling up the label space, but in order to provide the end user with critically important information on whether this device is useful in this specific case or not. Electrical parameters are stated for a very clear reason, as they determine if the end user can plug the device into the available electrical mains.

Now we come to the point of discussion which is frequently raised by manufacturers, to our great surprise, and this is whether the marking (and accompanying documentation) shall be provided in the local language. Any common user will probably be really bewildered by such a question. They in turn will ask: how can I operate or use the device, assuming I do not know any foreign languages? How could we generally speak about the safe and efficient operation or use of the device when the end user does not understand the text on the label? Moreover, let’s imagine we are interviewing a professor of linguistics in a university. “Sir or Madam, could you say that you understand the subject of your studies, i.e. the language itself, better than any native speaker?” Most probably the professor will tell you that he or she is not sure, i.e. it is really hard to know better than a native speaker, and when it comes to understanding the texts written in foreign languages, the users, when they are not native speakers, may have quite a disadvantage compared to the native speakers. Therefore, whether regulatory requirements for the localisation of labels exist or not in any particular jurisdiction, it is necessary to provide all important content of the label in the language of the assumed operational jurisdiction, or even provide multi-language labeling (several labels, each for the specific language).

4. Conclusions

Here is a brief summary of what shall be placed on the label and how it shall be done.

The label may or shall contain the following information:

1. The name of the device.
2. The model, catalogue ref number, etc.
3. The manufacturer’s information.
4. Information regarding the production facility.
5. Information regarding the authorised representative.
6. The serial number or lot/batch number.
7. The manufacturing date alone, or the manufacturing date and end date of the shelf life or end of use date.
8. The name of the device component.
9. The trade mark.
10. Reference to the accompanying documentation.
11. Permissive or prohibitive signs related to the proper application or use of the device concerned.
12. Related parameters and specifications.

And, of critical importance, all this should be provided in the local language.