Judgment;Summary — ECLI:EU:C:2023:34
Date: 2023-01-19
Language of the case: German
Court formation: Seventh Chamber
Subject matter: Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary C-495/21 – 1 
Case C-495/21 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
12 August 2021 
Referring court: 
Bundesverwaltungsgericht (Germany) 
Date of the decision to refer: 
20 May 2021 
Appellant on a point of law: 
L. GmbH 
Respondent in the appeal on a point of law: 
Federal Republic of Germany 
  
Subject matter of the main proceedings 
Pharmaceutical law – Directive 93/42 – Article 1(2)(a) – Directive 2001/83 – 
Article 1(2)(a) and Article 2(2) – Definition of substance-based medical devices 
and medicinal products 
Subject matter and legal basis of the request 
Interpretation of EU law, Article 267 TFEU 
Questions referred for a preliminary ruling 
1. Can the principal intended action of a substance be pharmacological within 
the meaning of Article 1(2)(a) of Directive 93/42/EEC even if it is not based 
on a receptor-mediated mode of action and the substance is not absorbed by 
the human body but remains on and reacts with the surface of, for example, 
the mucosa? On what criteria should a distinction be drawn between 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-495/21 
 
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pharmacological and non-pharmacological means, in particular physico-
chemical means, in such a case? 
2. Can a product be regarded as a substance-based medical device within the 
meaning of Article 1(2)(a) of Directive 93/42/EEC if, according to current 
scientific knowledge, the mode of action of the product is open to debate and 
it is thus not possible to definitively determine whether the principal 
intended action is achieved by pharmacological or physico-chemical means? 
3. In such a case, is the classification of the product as a medicinal product or 
as a medical device to be carried out on the basis of an overall assessment of 
its other properties and all other circumstances, or, in so far as it is intended 
to prevent, treat or alleviate diseases, is the product to be regarded as a 
medicinal product by presentation within the meaning of Article 1(2)(a) of 
Directive 2001/83/EC, irrespective of whether or not a specific medicinal 
effect is being claimed? 
4. Does the primacy of the regime governing medicinal products also apply in 
such a case in accordance with Article 2(2) of Directive 2001/83/EC? 
Provisions of European Union law relied on 
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 
1993 L 169, p. 1), last amended by Directive 2007/47/EC of the European 
Parliament and of the Council of 5 September 2007 (OJ 2007 L 247, p. 21), 
Article 1(2)(a) and Article (5)(c), Article 11(5) and point 13.3, letters (j) and (k) of 
Annex I 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 
5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation 
(EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council 
Directives 90/385/EEC and 93/42/EEC (OJ 2017 L 117, p. 1), recital 7 and 
Article 1(6)(b) 
Directive 2001/83/EC of the European Parliament and of the Council of 
6 November 2001 on the Community code relating to medicinal products for 
human use (OJ 2001 L 311, p. 67) as amended by Directive 2012/26/EU of the 
European Parliament and of the Council of 25 October 2012 (OJ 2012 L 299, 
p. 1), Article 1(2)(a) and (b), Article 2(2) and Article 59(1)(c)(iii) and 
Article 59(e) 
Succinct presentation of the facts and procedure in the main proceedings 
1 The applicant is an undertaking that produces various pharmaceutical products. It 
places on the market as a medical device a product containing, inter alia, the same 
active substance as nasal drops, which it also markets. As regards the application 
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of the product, the package information leaflet reads as follows: ‘The preparation 
is suitable for use with irritation of the nasal mucosa caused by viral rhinitis. It 
also soothes irritation of the nasal mucosa and supports its regeneration during a 
cold.’ It is indicated ‘for supporting the treatment of colds’ and ‘for treating 
colds’. In order to justify classification as a Class I medical device, the technical 
documentation of January 2011 indicates that the preparation’s principal action on 
the nasal mucosa is achieved by physico-chemical means. It has an astringent 
effect. It causes the outermost cell layer of the nasal epithelium to contract, 
thereby reducing nasal secretions. Furthermore, due to the contraction of the 
outermost cell layer of the nasal epithelium, a change in the membrane lipids to a 
gel-like state, which could influence the penetration of DNA into the epithelial 
cell, is conceivable. A further component of the product also has a physico-
chemical action, in so far as it forms an elastic film over the irritated nasal mucosa 
to prevent it drying out, thus soothing the nasal mucosa and supporting its 
regeneration. 
2 By decision of 16 January 2014, the competent authority ruled that the preparation 
is a medicinal product requiring marketing authorisation. It fulfils the 
requirements of a medicinal product by function, since the principal intended 
action is achieved by pharmacological means. The product is also to be regarded 
as a medicinal product by presentation. 
3 The authority dismissed the opposition brought against the abovementioned 
decision by decision of 14 October 2014. The action and the subsequent appeal 
were unsuccessful. The applicant is pursuing its claim by way of its appeal on a 
point of law. 
Succinct presentation of the reasoning in the request for a preliminary ruling 
4 The success of the action hinges on the way in which the scope of the rules 
governing medicinal products and medical devices are to be defined with respect 
to each other. There is a need for clarification with regard to the concept of 
‘pharmacological’ means within the meaning of Article 1(2)(a) of Directive 93/42 
(first question referred), how a product is to be classified when it cannot be 
clarified whether the principal intended action is achieved by pharmacological or 
physico-chemical means (second question referred), under what conditions a 
product placed on the market by the manufacturer as a Class I medical device is to 
be regarded as a medicinal product by presentation within the meaning of 
Article 1(2)(a) of Directive 2001/83 (third question referred) and whether the rule 
of priority for the law on medicinal products as set out in Article 2(2) of Directive 
2001/83 also applies to medicinal products by presentation (fourth question 
referred). 
5 In the case of a declaratory decision such as that at issue in the present case, the 
relevant date for assessing the factual and legal situation is the conclusion of the 
administrative procedure, meaning that Directive 93/42 applies in the present case. 
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The first question referred 
6 Pursuant to Article 1(5)(c) of Directive 93/42 (and Article 1(6)(b) of subsequent 
Regulation 2017/745), in deciding whether a product falls under the Medical 
Devices Directive (2001/83/EC) or under the provisions that apply to medical 
devices, particular account is to be taken of the principal mode of action of the 
product. The scope of the provisions must then be clearly defined with respect to 
one another (see also recital 7 of Regulation 2017/745). 
7 A definition of pharmacological action is necessary in order to clarify whether the 
principal mode of action of a product is achieved by pharmacological means. In 
accordance with the case-law of the Court of Justice, the guidelines issued by the 
European Commission – and thus in particular what is known as the ‘Borderline 
Guideline’ (European Commission, Medical Devices: Guidance Document, 
MEDDEV 2.1/3 rev 3, point A.2.1.1) – may be a useful reference in this respect. 
Under that provision, a pharmacological action is to be understood as an 
interaction between the molecules of the substance in question and a cellular 
constituent, usually referred to as a receptor, which either results in a direct 
response or blocks the response of another agent. The Court of Justice has held 
that a substance the molecules of which do not interact with a human cellular 
constituent may nevertheless, by means of its interaction with other cellular 
constituents present within the user’s organism, such as bacteria, viruses or 
parasites, have the effect of restoring, correcting or modifying physiological 
functions in human beings. It follows that it is not a priori inconceivable that a 
substance the molecules of which do not interact with a human cellular constituent 
may constitute a medicinal product within the meaning of Article 1(2)(b) of 
Directive 2001/83 (judgment of 6 September 2012, Chemische Fabrik Kreussler, 
C-308/11, EU:C:2012:548, paragraph 31 and 32). The reaction triggered by an 
active substance, which is not based on a receptor-mediated mode of action and in 
which the substance is not absorbed by the human body, but remains on the 
surface – for example of mucosa – cannot thus be classified a priori as a non-
pharmacological action. The formation of a ‘precipitation membrane’ resulting 
from the interconnection of the active substance with the mucosal proteins, as 
assumed by the defendant, could therefore be regarded as a pharmacological 
means. 
The second question referred 
8 In accordance with the binding factual findings made in the judgment of the 
appellate court, according to current scientific knowledge, it is not possible to 
clarify whether the principal intended action of the product is achieved by 
pharmacological or physico-chemical means. In such a case, it is not clear how 
and according to what criteria classification is to be made to a category of product. 
9 The fact that Article 1(5)(c) of Directive 93/42 does not preclude other criteria 
from being taken into account could argue against a solution based on the 
principles of the burden of proof. Accordingly, it is instead necessary to take into 
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consideration only ‘in particular’ the principal mode of action of the product. If 
this cannot be clarified, the legislation should therefore not exclude recourse to 
other criteria. On the contrary, all of the characteristics of the product could then 
be taken into account, such as the significance of the action on human 
physiological properties or the potential risks to the health of the user. As in the 
decision as to whether a product falls under the definition of a medicinal product, 
an overall assessment of the product could then be carried out on a case-by-case 
basis. The classification of a product under the term ‘medical device’ would 
therefore be possible even if its non-pharmacological action cannot be positively 
established. 
The third question referred 
10 Under Article 1(2)(a) of Directive 2001/83, any substance or combination of 
substances presented for treating or preventing disease in human beings is a 
medicinal product (known as a medicinal product ‘by presentation’). 
11 As substance-based medical devices are also intended, in accordance with the first 
indent of Article 1(2)(a) of Directive 93/42, to alleviate, prevent or treat diseases, 
there is no difference between medical devices and medicinal products as regards 
their intended therapeutic purpose. Information provided to that effect in the use 
instructions is not on its own a suitable criterion for distinguishing between the 
two in this respect. There is thus doubt as to whether a product placed on the 
market by the manufacturer as a Class I medical device within the meaning of 
Article 11(5) of Directive 93/42 is then capable of being regarded as a medicinal 
product within the meaning of Article 1(2)(a) of Directive 2001/83 if it is by 
presentation intended to treat or alleviate diseases, but does not claim any specific 
medicinal effect. 
12 While mere classification as a medical device on the part of the manufacturer does 
not make presentation as a medicinal product impossible on the basis of the 
overall impression produced by the packaging, the manufacturer’s information 
must be taken into account as part of the presentation of the product. It may be 
‘persuasive evidence’ for the interpretation (see judgment of 21 March 1991, 
Delattre, C-369/88, EU:C:1991:137, paragraph 41). A CE mark affixed to the 
packaging of the product may also be significant in this respect. It cannot in 
principle be assumed that a reasonable average consumer will consider a 
preparation expressly offered as a medical device to be a medicinal product. 
Special additional circumstances are required for this. 
13 The reference to an intended therapeutic purpose should not be sufficient in any 
event to substantiate such evidence where the product is not promoted as having 
specific medicinal actions. A medical device may also be presented to treat 
irritation of the nasal mucosa caused by viral rhinitis. By providing such 
information, the manufacturer is not creating the impression of a medicinal 
product, but is instead indicating the intended purpose of a medical device, as 
required by law (see also, in relation to the indication of the intended purpose of a 
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cosmetic product, judgment of 17 December 2020, A.M. (Étiquetage des produits 
cosmétiques), C-667/19, EU:C:2020:1039). 
14 Nor should the reference to ‘interactions’ and ‘adverse effects’ lead to the 
conclusion that the product is being presented in a specifically medicinal manner. 
Although it is true that such information bears some similarity to the compulsory 
information that must appear on the package leaflet of a medicinal product (see 
Article 59(1)(c)(iii) and Article 59(1)(e) of Directive 2001/83), the information 
required for labelling medical devices in accordance with point 13.3 of Annex I to 
Directive 93/42 also includes special operating instructions (j) and warnings 
and/or information on any precautions to be taken (k). 
15 Finally, the fact that the product is distributed through pharmacies should not 
constitute a special circumstance in support of the applicant presenting it as a 
medicinal product rather than a medical device. This is because pharmacy-
exclusive distribution is not reserved for medicinal products under German law, 
but is instead also provided for in respect of certain medical devices. 
The fourth question referred 
16 Under Article 2(2) of Directive 2001/83, in cases of doubt, where, taking into 
account all its characteristics, a product may fall within the definition of a 
‘medicinal product’ and within the definition of a product covered by other EU 
legislation the provisions of this Directive shall apply. 
17 The primacy thus accorded to the regime governing medicinal products applies to 
‘medicinal products’ and also refers, by its wording, to medicinal products by 
presentation, within the meaning of Article 1(2)(a) of Directive 2001/83. Only a 
medicinal product by function, within the meaning of Article 1(2)(b) of Directive 
2001/83, may have ‘characteristics’ that must be taken into account in accordance 
with Article 2(2) of Directive 2001/83. The pharmacological, immunological or 
metabolic properties of a product constitute the factor on the basis of which it 
must be ascertained whether it may be used with a view to restoring, correcting or 
modifying physiological functions (judgment of 3 October 2013, Laboratoires 
Lyocentre, C-109/12, EU:C:2013:626, paragraph 43). By contrast, the concept of 
a medicinal product by presentation is conceived in broad terms, referring, in 
particular, only to claimed ‘characteristics’ of the product that are not actually 
present (judgment of 15 January 2009, Hecht-Pharma, C-140/07, EU:C:2009:5, 
paragraph 25). It would therefore also be conceivable to limit the rule of priority 
to medicinal products by function within the meaning of Article 1(2)(b) of 
Directive 2001/83. 
18 This could also be supported by the fact that, in cases where a pharmacological 
action of the substance has not been established, there should be no reason to 
accord primacy to the law on medicinal products. Although it is true that the 
consumer must be protected from products which do not have the effectiveness 
they would be expected to have on the basis of their presentation, as long as the 
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product falls under the definition of another product, such as a medical device 
within the meaning of Article 1(2)(a) of Directive 93/42, that protection may also 
result from the laws that apply to that product (see judgment of 3 October 2013, 
Laboratoires Lyocentre, C-109/12, EU:C:2013:626, paragraph 53). Those rules 
are likely to be more relevant than those of the law on medicinal products, in light 
of the actual characteristics of the product. The application of the law on 
medicinal products could therefore prove to be a disproportionate restriction on 
the free movement of goods.