Opinion of the Advocate General — ECLI:EU:C:2012:299
Date: 2012-05-15
Language of the case: German
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Germany

Summary 62. Clearly, there are many factors to suggest that an exclusively literal interpretation of the definition of ‘medical device’ given in Directive 93/42 is not satisfactory. On the contrary, it seems more appropriate to restrict the scope of the directive and, more specifically, the scope of the third indent of Article 1(2)(a) solely to devices which are intended to be used for a medical purpose. 63. An element of clarification is needed here, however. Even if the information provided by the manufacturer is the key factor in determining whether a product is intended to be used for a medical purpose, any product which, by its very nature, is clearly intended to be used solely for a purpose of a medical nature will have to be regarded as a medical device, even if the manufacturer does not describe it as such. In any event, that proviso, which is designed to prevent abuse, ought not to be needed in most cases, since – including for obvious reasons of professional liability – the consistent practice of medical structures is to purchase only products which have been certified in accordance with the directive. 64. Furthermore, the fact that a product has not been categorised as a medical device should not be taken to imply that it may present a particular risk for users. All of the other general provisions to guarantee product safety continue to apply, including those which, for example, require conformity and the affixing of the CE marking to all electrical equipment, (21) to all equipment which could cause problems relating to electromagnetic compatibility (22) and so on. Paradoxically, as the Commission emphasised at the hearing, in many cases, other forms of certification lay down requirements which are even more stringent than those imposed in relation to medical devices. While a medical device may, generally, entail risks, including significant risks, provided that those risks are offset by adequate benefits, the other forms of certification do not, in the majority of cases, permit a similar balance to be struck and tend simply to require that any possible risk be minimised. V – Conclusion 65. In the light of the foregoing considerations, I propose that the Court reply as follows to the question referred for a preliminary ruling by the Bundesgerichtshof: A product which is intended by the manufacturer to be applied for human beings for the purpose of investigation of a physiological process constitutes a medical device, within the terms of the third indent of Article 1(2)(a) of Directive 93/42/EEC, only where it is intended for a medical purpose. 1 – Original language: Italian. 2– Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as amended. 3 – OJ 1985 C 136, p. 1. 4– Council Directive 88/378/EEC of 3 May 1988 on the approximation of the laws of the Member States concerning the safety of toys (OJ 1988 L 187, p. 1). 5– Council Directive 93/15/EEC of 5 April 1993 on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil uses (OJ 1993 L 121, p. 20). 6– Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (OJ 1995 L 91, p. 10). 7– Directive 95/16/EC of the European Parliament and of the Council of 29 June 1995 on the approximation of the laws of the Member States relating to lifts (OJ 1995 L 213, p. 1). 8 – Commission communication in the framework of the implementation of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Publication of titles and references of harmonised standards under the directive) (OJ 2011 C 242, p. 8). 9 – The document is available on the Commission’s website. At the date of this Opinion, the list of the guidelines relating to medical devices may be consulted at: http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm. 10 – Paragraph 1.1(b) of the document. Emphasis added, although, in the Commission’s text, the expression ‘medical purpose’ is underlined. 11 – See also, in that connection, the third and fifth recitals in the preamble which refer to safety and protection for ‘patients’, ‘users’ and ‘third parties’. 12– Emphasis added. 13– Directive 2001/83/EC of the 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). See, in particular, the fourth and fifth recitals in the preamble. 14 – See, for example, Case C‑319/05 Commission v Germany [2007] ECR I‑9811, paragraphs 62 and 71; and Case C‑140/07 Hecht-Pharma [2009] ECR I‑41, paragraph 27. See also, by analogy, Case C‑6/05 Medipac-Kazantzidis [2007] ECR I‑4557, paragraph 52. 15– Emphasis added. 16 – At best, that profile could be neutral in the case of devices involving no risk – not even a minimal risk. On the other hand, as we know, there is no such thing as zero risk in the real world. 17 – In some cases, certain products are certified as medical devices even though they are mainly intended for non-professionals. That is a result of a commercial decision by manufacturers, linked to the product’s image and often connected to a higher product price. 18 – The referring court, which is against limiting the requirement of conformity to Directive 93/42 exclusively to products intended for medical use, considers it in any event possible to rule out the application of the directive to products with regard to which the ‘investigation of a physiological process’ is not the ‘purpose’ of the actual product, but merely the ‘means’ of achieving a different purpose. In my view, that distinction does not carry conviction: the purpose of a heart-rate monitor for use in the home is to measure heart rate, just like the ECG component in the ActiveTwo system. If what the referring court is proposing is an analysis of the further purpose for which the product may be intended (weight loss, improving physical fitness and so on), I would point out that this brings us back to the realm of a subjective assessment, just like the manufacturer’s assessment of the intended use of the product. Taking that approach, if it is necessary to ascertain the ultimate purpose for which a ‘domestic’ heart-rate monitor is intended, it will also be necessary to determine the ultimate purpose for which the ActiveTwo system is intended: the conclusion is that there is no medical purpose in either case. 19 – As pointed out at the hearing also, there is no doubt that, for example, an implantable prosthesis will also constitute a medical device, as it is implanted during a surgical procedure. Whether the prosthesis is implanted for therapeutic or for purely aesthetic reasons is therefore irrelevant. 20 – See also the Commission’s guidelines, MEDDEV 2.1/1, cited in footnote 9, paragraph I.1(d). 21– Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version) (OJ 2006 L 374, p. 10). 22– Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility and repealing Directive 89/336/EEC (OJ 2004 L 390, p. 24).