Intended purpose or intended use? And what's the right translation?

Terminological consistency is one of the principles shared by technical writers and translators. In specialised texts, synonyms do not serve as a stylistic device to enrich a text; on the contrary, they have a negative effect on quality by generating confusion. By reading Article 2 of the European medical device regulation, it is clear that lawyers and legislators are also well aware of the importance of consistency and the accurate definition of terms to be used in a legal text.
However, whether you work for a medical device manufacturer as a regulatory affairs officer, or whether you are a PRRC, a consultant or an authorised representative, or whether you are part of a notified body, or even whether you are a senior European Commission official dealing with medical devices, at some point you may have asked yourself whether 'intended purpose' is the same as 'intended use'.
Although you have probably already found the answer, during my search I have been surprised to find a few industry professionals who are still somewhat confused. I already had this feeling following my online research, but I was able to confirm it after attending the 8th conference of the European Association of Authorised Representatives that took place in Brussels on 26-27 February, organised by Bioevents.
To add further intrigue to this story, I should add that this confusion "was not lost in translation", but rather multiplied. As we will analyse in this article, the translation of Regulation 2017/745 on Medical Devices and Regulation 2017/746 on In Vitro Diagnostic Medical Devices introduced new inconsistencies, regardless of whether we question the appropriateness of the translations given to a key term such as 'intended purpose'.
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- Why is the concept of 'intended purpose' so important?
- 'Intended purpose' versus 'intended use'
- Which term should be used: 'intended purpose' or 'intended use'?
- And in German: Zweckbestimung or bestimungsgemäße Verwendung?
- And in French: destination or utilisation prévue?
- And in Italian: destinazione d'uso or uso previsto?
- And in Spanish: finalidad prevista or uso previsto?
- Criteria to be adopted to resolve terminological inconsistencies in regulations
Why is the concept of 'intended purpose' so important?
Even if you have very little experience working with the medical device regulation, you may have already heard how relevant this concept is in the framework of the regulation.
In the English version, Article 2, paragraph 12, defines 'intended purpose' as: "the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation".
The most relevant impact of what we describe as the intended purpose of a medical device is that it will determine the risk classification of the device, to such an extent that the same device may be classified under a different risk category depending on its intended purpose.
The implications of the risk classification of our devices will be greater, as this classification will determine the route towards product certification with major differences in the legal requirements, i.e. the time and money we will have to invest to ultimately sell our devices in the EU.
'Intended purpose' versus 'intended use'
It should first be noted that Article 2 only defines 'intended purpose', a term that appears up to 85 times in the articles of the regulation and its annexes. 'Intended use' appears for the first and only time in Article 61, and 13 times in Annex V on clinical evaluation. It can be concluded that the writers of Annex V did not take Article 2 of the regulation into account.
In fact, in the context of the regulation, no conceptual difference should be made between the two terms. When the regulation refers to 'intended use', it means 'intended purpose' with all the implications that this entails. This was made clear in the MDGC-6 guide, which literally states that "'intended use' should be considered to have the same meaning as 'intended purpose'".
There are quite reasonable interpretations, perhaps inspired by the term 'intended use' used by the FDA, in which 'intended use' is understood as a part of the different elements implied by the concept of 'intended purpose': target population, geographical scope, etc.
Which term should be used: 'intended purpose' or 'intended use'?
If we have concluded that both terms mean the same thing, can we therefore use them interchangeably? Theoretically yes, but it makes no sense to replicate the lack of terminological coherence introduced by the European legislator, or more precisely, legislators. It is obvious that the regulation has been written by different people and this is probably the root cause.
In English we can see that the use of 'intended purpose' is more widespread, although it is not uncommon to find the term 'intended use', either because of its literal translation of terms more commonly used in other languages or because the English documentation was first developed for the American market, a current trend that is increasing due to the difficulty and cost of obtaining European certification.
It is advisable to use 'intended purpose' at all times and forget about 'intended use'. 'Intended purpose' is the term defined as such in the MDR and the most widely used.
We will look now at the translations into the languages of the main European markets: German, French, Italian and Spanish. What happens with this inconsistency introduced by the original English text?
And in German: Zweckbestimung or bestimungsgemäße Verwendung?
Let's start by saying that Zweckbestimung is the German translation found in the regulation for 'intended purpose'. 'Intended use' is translated generally as bestimungsgemäße Verwendung, 13 times to be precise, but we can also find it translated as Zweckbestimung on two occasions and it may seem that the translator wanted to solve the inconsistency problem in the original text, except that 'intented use' is also translated as bezweckte Verwendung.
That said, we can say that the use of Zweckbestimung is quite well established among German manufacturers and is widely used, although it could be argued that, theoretically, bestimungsgemäße Verwendung has the same meaning, but as we have already said its use does not provide any benefits, quite the opposite.
And in French: destination or utilisation prévue?
Despite the surprised and disbelieving faces of many native French speakers, our strategy as a translation company is to translate both ‘intended purpose' and 'intended use' as destination.
It must be said that the French version is probably the most coherent of those analysed. Except on one occasion when it is translated simply as utilisation, 'intended use' is consistently translated as utilisation prévue.
However, in Article 74, 'intended purpose' becomes destination prévue, in Article 120(3) it becomes finalité and in Annex VI, Part C, 1, Definitions, Configuration it becomes objectif donné, instead of using the translation found in Article 2, i.e. destination.
But the most important argument for adopting destination as the best translation for 'intended purpose' is that destination is the term defined in Article 2, paragraph 12 of the French version of regulation 2017/745:
"«Destination», l'utilisation à laquelle un dispositif est destiné d'après les indications fournies par le fabricant sur l'étiquette, dans la notice d'utilisation ou dans les documents ou indications publicitaires ou de vente, et comme celles présentées par le fabricant dans l'évaluation clinique".
From a legal point of view, destination has no possible interpretation other than that defined in the regulation itself.
This term may sound strange to most native French speakers not involved in the regulation, but it is the solution adopted by the French translator in most cases and is part of French national law. As we shall see, this unidiomatic translation is not unique to the French version.
And in Italian: destinazione d'uso or uso previsto?
Before answering this question, it must be said that the Italian translator (or translators) were the most imaginative. The term 'intended use' has 6 different versions in Italian!
From most to least frequent, 'intended use' has been translated as destinazione d'uso (7), uso previsto (3), utilizzo previsto (2), usi cui detti dispositivi sono destinati (2), usi cui sono destinati (1) and utilizzazione prevista (1).
Ironically, considering that the Italian version is the most inconsistent with regard to the translation of 'intended use', it is also the language in which the translator most often resolves the inconsistency introduced by the legislator in the original English version, by translating 'intended use' as destinazione d'uso, i.e. the term defined in Article 2 of the Italian version.
As in the case of French or Spanish, the translation of 'intended purpose' is not idiomatic to the native Italian. In other words, it is not widely used outside the context of the regulation, but destinazione d'uso is the term explicitly defined in Article 2, paragraph 12 of the MDR:
"«destinazione d'uso»: l'utilizzo al quale è destinato un dispositivo secondo le indicazioni fornite dal fabbricante sull'etichetta, nelle istruzioni per l'uso o nel materiale o nelle dichiarazioni di promozione o vendita e come specificato dal fabbricante nella valutazione clinica".
As with all other languages, at AbroadLink we translate 'intended purpose' and 'intended use' as destinazione d'uso. We understand that in the context Italian readers will understand what the term is referring to and the manufacturer will be using the legally defined term in Italian law, an infallible argument before any body, including notified bodies.
And in Spanish: finalidad prevista or uso previsto?
The Spanish is also more incoherent than the original English version if we analyse the translation given to 'intended use'. Uso previsto is the most common translation, appearing 14 times, but we can also find intended use translated as utilización prevista or finalidad prevista.
Criteria to be adopted to resolve terminological inconsistencies in regulations
Regardless of more widespread and idiomatic uses, the translation of 'intended purpose' should be that used in Article 2, paragraph 12 of European Regulation 2017/745 on Medical Devices for the different languages of the European Union.
The official translations of the regulations are the legal text and thus constitute the legal terminology of the European Union. From a regulatory and legal point of view, it can be understood that this terminology must be used, or at least it is advisable to use it in order to avoid the confusion that the incoherent use of terminology entails, the first exponent of which is the regulation itself in its original version and its official translations.
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Josh Gambin holds a 5-year degree in Biology from the University of Valencia (Spain) and a 4-year degree in Translation and Interpreting from the University of Granada (Spain). He has worked as a freelance translator, in-house translator, desktop publisher and project manager. From 2002, he is a founding member of AbroadLlink and currently works as Marketing and Sales Manager.
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