Probably the most important step in the development of a medical device, from the idea to the approval, is the definition of the intended purpose. This is decisive for the determination of the risk class and the selection of the corresponding essential requirements, even the legal basis that must be fulfilled. If nothing else, the intended purpose is the most important claim for the product and has an influence on all following product claims with which you may gain the interest of customers – in short, it is the core of the product.
However, despite the central position of this term, the legislator has unfortunately not succeeded in clearly defining the term in all languages of the Medical Device Regulation (MDR (EU) 2017/745). Or how are the terms “intended purpose” and “intended use” used in your company? Is there a difference? Or do both mean the same thing? In this article, we would like to clear things up and make a comparison and analyze the use of the mentioned terms in English as well as in German, showing what aspects must be considered when working in a bilingual environment. Let’s approach the problem in a systematic way:
The first and most important source to consider is the MDR. Of course, there are other sources such as standards (ISO 14971, 24971) or guidance documents (e.g. the MEDDEV 2.7/1 Rev. 4 or MDCG guidelines). However, the MDR as a regulation is the only legally binding basis, which is why it is worth taking a closer look here.
Definitions MDR
The first look here is taken on Article 2, where the definitions are listed.
Art. 2, 12:
In the English version it says:
‘intended purpose’ means 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; ((EU) 2017/745)
The German version contains this wording:
„Zweckbestimmung“ bezeichnet die Verwendung, für die ein Produkt entsprechend den Angaben des Herstellers auf der Kennzeichnung, in der Gebrauchsanweisung oder dem Werbe- oder Verkaufsmaterial bzw. den Werbe- oder Verkaufsangaben und seinen Angaben bei der klinischen Bewertung bestimmt ist; ((EU) 2017/745)
Following this it would be easy:
intended purpose = Zweckbestimmung
If you search the German version of the MDR for the keyword “Zweckbestimmung” and check the English edition at these points, you get this pair of words exactly 84 (!) times.
But unfortunately, there are 2 passages where ”Zweckbestimmung” is not translated as intended purpose, but as intended use:
Annex I, 10.3:
The English version now suddenly says:
“Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.“
Whereas the German version says:
„Die Produkte werden so ausgelegt und hergestellt, dass eine sichere Anwendung in Verbindung mit Werkstoffen und Stoffen, einschließlich Gasen, mit denen sie bei bestimmungsgemäßer Anwendung in Kontakt kommen, gewährleistet ist; sind die Produkte zur Verabreichung von Arzneimitteln bestimmt, werden sie so ausgelegt und hergestellt, dass sie entsprechend den für diese Arzneimittel geltenden Bestimmungen und Beschränkungen mit den Arzneimitteln verträglich sind und dass die Leistung sowohl der Arzneimittel als auch der Medizinprodukte entsprechend ihrer Gebrauchsanweisung und Zweckbestimmung aufrechterhalten bleibt.“
The same applies to another general safety and performance requirement:
Annex I, 16.4 b:
The English version says:
Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled and, if possible, monitored during treatment.”
The wording of the German version:
„Produkte, die zum Aussenden ionisierender Strahlung bestimmt sind, werden so ausgelegt und hergestellt, dass — soweit möglich — unter Berücksichtigung ihrer Zweckbestimmung die Quantität, die Geometrie und die Qualität der ausgesandten Strahlung verändert und kontrolliert und — soweit möglich — während der Behandlung überwacht werden können.“
Consequently, the second pair of words is:
Intended use = Zweckbestimmung
To investigate this, let’s put the sample to the test – starting with the English version of the MDR, let’s now search for “intended use” and the corresponding equivalents in German:
Another pair of words is introduced, namely:
Intended use = bestimmungsgemäße Verwendung
Article 61, 1:
In the English version:
Confirmation of conformity with the relevant general safety and performance requirements set out in Annex I under normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk-ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.
And the German version:
Die Bestätigung der Erfüllung der einschlägigen grundlegenden Sicherheits- und Leistungsanforderungen gemäß Anhang I bei normaler bestimmungsgemäßer Verwendung des Produkts sowie die Beurteilung unerwünschter Nebenwirkungen und der Vertretbarkeit des Nutzen-Risiko-Verhältnisses gemäß Anhang I Abschnitte 1 und 8 erfolgen auf der Grundlage klinischer Daten, die einen ausreichenden klinischen Nachweis bieten, gegebenenfalls einschließlich einschlägiger Daten gemäß Anhang III.
This corresponding pair is found in a total of 12 other passages in the MDR.
At another point, even with a very unsatisfactory vagueness – here, the term “use” specified more precisely in German by means of “bestimmungsgemäß” is rendered in English merely without any further specification:
Art. 2, 24
In the English version:
“[…] the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;”.
And in the German version:
…„[…] die Analyse aller Bewertungen des Nutzens und der Risiken, die für die Bestimmungsgemäße Verwendung eines Produkts entsprechend der vom Hersteller angegebenen Zweckbestimmung von möglicher Relevanz sind;“
Art 2, 24:
The use = Die Bestimmungsgemäße Verwendung
An almost Babylonian confusion of language – not considering the other +20 language versions of the MDR! The legislator fails to create clarity for those affected – presumably due to different authors for different parts of the MDR (and perhaps also translators) who have obviously not been coordinated.
This seems to have been recognised afterwards, because there was an attempt to clarify the situation by means of an MDCG paper. Unfortunately, this went entirely wrong and is only available in English.
MDCG 2020-6, which addresses clinical evidence for legacy products, postulates the equation and synonymity of “intended purpose” and “intended use” in the definitions. The statement is based on the fact that these terms describe the effect of a product and are therefore to be clearly distinguished from the indication of the products, which refers to the clinical condition.
The equation of the two terms is also proposed in the definitions of ISO 14971:2019. What is striking, however, is the fact that the note attached to ISO 14971 clearly states that the indication of a medical device is to be considered an essential component of the intended purpose. Other common components are defined as the patient population, the body part or tissue type for which the application is intended, the user profile, the application environment, and the functionality.
Ultimately, what remains is:
- The legal basis (the MDR (EU) 2017/745) is confusing and unclear because definitions are missing and terms are sometimes arbitrarily used synonymously.
- The MDCG Guidance equates the terms “intended purpose” and “intended use”.
- ISO 14971 also equates the terms and contradicts the MDCG and Annex II of the MDR with the supplementary explanation of the components.
Both of the latter sources are not legally binding. What could a solution look like?
Proposal for a solution approach for the intended purpose
Unfortunately, the solution is not clearly described, but can rather be discovered gradually from a bird’s eye view. As soon as one is confronted with creating technical documentation and establishing rules for the allocation of the Basic UDI-DI in one’s QM system, a clearer picture slowly emerges.
Chapter 1.1 in Annex II is an often underestimated part of the technical documentation. It is about the device description. In the subitem
- a) we read “intended purpose”, but additionally “intended user”; further in
- c) ‘patient population, ‘medical condition’, ‘indications’; and
- d) “principle of operation”, etc. –
this is very reminiscent of the definition from risk management. Without these additional points, it is indeed not possible to create a risk management according to the state of the art. Of course, this information is needed for a clinical evaluation. But not in every case this comprehensive definition will be stated as intended purpose on the packaging. Our recommendation: understand intended purpose (= Zweckbestimmung) as a subset of intended use (= Bestimmungsgemäßer Gebrauch). This will also help to structure your products into Basic UDI-DIs and can be represented as follows:
This representation is suitable for the EU. It does not represent the “intended use” as understood by the FDA.
It probably really doesn’t matter whether you talk about “intended purpose” or “intended use”. But make sure that everyone in your company is aware of the understanding of the term “intended purpose” as opposed to “intended use” and when these are to be referred to respectively. Do you still not feel up to the task yet despite intense discussion? We would be happy to support you in developing your intended purposes and/or intended use.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
