Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto.

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• Date: 30 May 2013

OPINION OF ADVOCATE GENERAL

SHARPSTON

delivered on 30 May 2013 (1 )

Case C‑109/12

Laboratoires Lyocentre

(Request for a preliminary ruling from the Korkein hallinto-oikeus (Finland))

‛Medicinal product — Medical device — CE marking — Product classification — Procedure’

1. A product previously classified by the competent authorities of a Member State as a medical device has been reclassified as a medicinal product. That product remains on the market in some other Member States as a medical device. Against that background, the Court is asked to determine what procedures should apply to such a reclassification and whether a product can be both a medical device and a medicinal product in (i) the market of a single Member State and (ii) the internal market.

Legal background

EU law

Medical Devices Directive

2. Council Directive 93/42/EEC concerning medical devices (‘the Medical Devices Directive’) (2) applies to medical devices and their accessories which are collectively termed ‘devices’ for purposes of that directive. (3)

3. The third recital in the preamble states that ‘national provisions for the safety and health protection of patients, users and, where appropriate, other persons, with regard to the use of medical devices should be harmonised in order to guarantee the free movement of such devices within the internal market’.

4. The sixth recital states that: ‘… certain medical devices are intended to administer medicinal products within the meaning of Council Directive 65/65/EEC [ (4) ] …; in such cases, the placing on the market of the medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by [the Medicinal Products Directive]; … if, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral unit which is intended exclusively for use in the given combination and which is not reusable, that single-unit product shall be governed by [the Medicinal Products Directive]; … a distinction must be drawn between the abovementioned devices and medical devices incorporating, inter alia, substances which, if used separately, may be considered to be a medicinal substance within the meaning of [the Medicinal Products Directive]; … in such cases, if the substances incorporated in the medical devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is governed by this Directive …’

5. The 17th recital states that ‘medical devices should, as a general rule, bear the CE mark to indicate their conformity with the provisions of this Directive to enable them to move freely within the Community and to be put into service in accordance with their intended purpose’.

6. Article 1(2)(a) defines a ‘medical device’ as: (5) ‘any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, — investigation, replacement or modification of the anatomy or of a physiological process, — control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.’

7. Article 1(3) states: ‘Where a device is intended to administer a medicinal product within the meaning of Article 1 of [the Medicinal Products Directive], that device shall be governed by the present Directive, without prejudice to the provisions of [the Medicinal Products Directive] with regard to the medicinal product. If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by [the Medicinal Products Directive]. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned.’

8. According to Article 1(5)(c), the Medical Devices Directive does not apply to ‘medicinal products covered by [the Medicinal Products Directive]’. Directive 2007/47 adds a sentence stating that ‘[i]n deciding whether a product falls under [the Medicinal Products Directive] or this Directive, particular account shall be taken of the principal mode of action of the product’.

9. Article 2 provides: ‘Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose.’

10. According to Article 3, ‘devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned’. Article 5(1) provides that Member States must presume compliance with those requirements ‘in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonised standards …’.

11. Article 4(1) provides: ‘Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking provided for in Article 17 which indicate that they have been the subject of an assessment of their conformity in accordance with the provisions of Article 11.’

12. Article 8 sets out the ‘Safeguard clause’: ‘1. Where a Member State ascertains that the devices referred to in Article 4(1) and (2), second indent, when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to: (a) failure to meet the essential requirements referred to in Article 3; (b) incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied; (c) shortcomings in the standards themselves. … 3. Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof. …’

13. Article 9 provides that devices are to be divided into Classes I, IIa, IIb and III. Article 11 sets out the conformity assessment procedures that apply to each class.

14. Article 17(1) states: ‘Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.’

15. Article 18 concerns ‘Wrongly affixed CE marking’ and provides: ‘Without prejudice to Article 8: (a) where a Member State establishes that the CE marking has been affixed unduly, [ (6)] the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State; (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8. Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’

Medicinal Products Directive

16. Directive 2001/83/EC on the Community code relating to medicinal products for human use (‘the Medicinal Products Directive’) (7) defines, in Article 1(2), a ‘medicinal product’ as: ‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

17. The present wording of that provision is based on the amendment by Directive 2004/27. (8) Recital 7 in the preamble to the latter states: ‘In order to take account both of the emergence of new therapies and of the growing number of so-called “borderline” products between the medicinal product sector and other sectors, the definition of “medicinal product” should be modified so as to avoid any doubt as to the applicable legislation when a product...