Case C‑109/12

Laboratoires Lyocentre

v

Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto

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

‛Reference for a preliminary ruling — Approximation of laws — Medical devices — Directive 93/42/EEC — Medicinal products for human use — Directive 2001/83/EC — Right of the competent national authority to classify as a medicinal product for human use a product marketed in another Member State as a medical device bearing a CE marking — Applicable procedure’

Summary — Judgment of the Court (Fourth Chamber), 3 October 2013

1. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Criteria

   (European Parliament and Council Directive 2001/83)

2. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Distinction between medicinal products and medical devices — Criteria — Product classified in one Member State as a medical device, in accordance with Directive 93/42, and in another Member State as a medicinal product, in accordance with Directive 2001/83 — Whether permissible

   (European Parliament and Council Directive 2001/83, Art. 1(2)(b); Council Directive 93/42, Art. 1(2)(a) and (5)(c))

3. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Classification as a medicinal product of a product already classified in another Member State as a medical device — Procedures applicable under the directives

   (European Parliament and Council Directive 2001/83; Council Directive 93/42, Arts 8 and 18)

4. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Marketing of a product as a medicinal product or as a medical device — Product not identical to another product classified as a medicinal product, but having in common with it an identical substance and the same mode of action — Marketing of that product as a medical device — Not permissible — Exceptions — Verification by the national court

   (European Parliament and Council Directive 2001/83; Council Directive 93/42, Arts 1(2)(a), 8 and 18)

1.  See the text of the decision.

   (see paras 42, 43)

2.  The classification of a product in one Member State as a medical device bearing a CE marking, in accordance with Directive 93/42 concerning medical devices, as amended by Directive 2007/47, does not preclude the competent authorities of another Member State from classifying the same product, on the basis of its pharmacological, immunological or metabolic action, as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1901/2006.

   In this connection, as regards the distinction between medicinal products and medical devices, Article 1(5)(c) of Directive 93/42 specifically requires the competent authorities to take particular account of the principal mode of action of the product. Under Article 1(2)(a) of that directive, only a product which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means may be classified as a medical device.

   None the less, as EU law currently stands, until harmonisation of the measures necessary to ensure the protection of health is more complete, it will be difficult to avoid the existence of differences in the classification of products as between Member States in the context of Directive 2001/83.

   Asymmetries in scientific information, new scientific developments and differing assessments of risks to human health and the desired level of protection can explain why different decisions are taken by the competent authorities of two Member States as regards the classification of a product.

   Moreover, the fact that a product is classified as a medical device in accordance with Directive 93/42 in one Member State does not prevent it being classified, in another Member State, as a medicinal product in accordance with Directive 2001/83 if it displays the characteristics of such a product.

   (see paras 44-48, operative part 1)

3.  In order to classify as a medicinal product in accordance with Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1901/2006, a product already classified in another Member State as a medical device bearing a CE marking, in accordance with Directive 93/42 concerning medical devices, as amended by Directive 2007/47, the competent authorities of a Member State must, before applying the classification procedure under Directive 2001/83, apply the procedure under Article 18 of Directive 93/42, and, where appropriate, the procedure under Article 8 of Directive 93/42.

   In this connection, the competent authorities of a Member State must regard the CE marking, affixed to the product following its classification as a medical device in that other Member State, as having been affixed inappropriately.

   (see paras 53, 55, operative part 2)

4.  Within the same Member State, a product which, while not identical to another product classified as a medicinal product, none the less has in common with it an identical substance and the same mode of action, cannot, in principle, be marketed as a medical device in accordance with Directive 93/42 concerning medical devices, as amended by Directive 2007/47, unless, as a result of another characteristic that is specific to that product and relevant for the purposes of Article 1(2)(a) of Directive 93/42, it must be classified and marketed as a medical device, which is a matter for the national court to verify.

   Moreover, 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, it must be classified as a medicinal product.

   (see paras 59, 60, operative part 3)

Case C‑109/12

Laboratoires Lyocentre

v

Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto

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

‛Reference for a preliminary ruling — Approximation of laws — Medical devices — Directive 93/42/EEC — Medicinal products for human use — Directive 2001/83/EC — Right of the competent national authority to classify as a medicinal product for human use a product marketed in another Member State as a medical device bearing a CE marking — Applicable procedure’

Summary — Judgment of the Court (Fourth Chamber), 3 October 2013

1. Approximation of laws — Medicinal products for human use — Directive 2001/83 — Classification of a product as a medicinal product by function — Criteria

   (European Parliament and Council Directive 2001/83)

2. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Distinction between medicinal products and medical devices — Criteria — Product classified in one Member State as a medical device, in accordance with Directive 93/42, and in another Member State as a medicinal product, in accordance with Directive 2001/83 — Whether permissible

   (European Parliament and Council Directive 2001/83, Art. 1(2)(b); Council Directive 93/42, Art. 1(2)(a) and (5)(c))

3. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Classification as a medicinal product of a product already classified in another Member State as a medical device — Procedures applicable under the directives

   (European Parliament and Council Directive 2001/83; Council Directive 93/42, Arts 8 and 18)

4. Approximation of laws — Medicinal products for human use — Directives 93/42 and 2001/83 — Marketing of a product as a medicinal product or as a medical device — Product not identical to another product classified as a medicinal product, but having in common with it an identical substance and the same mode of action — Marketing of that product as a medical device — Not permissible — Exceptions — Verification by the national court

   (European Parliament and Council Directive 2001/83; Council Directive 93/42, Arts 1(2)(a), 8 and 18)

1.  See the text of the decision.

   (see paras 42, 43)

2.  The classification of a product in one Member State as a medical device bearing a CE marking, in accordance with Directive 93/42 concerning medical devices, as amended by Directive 2007/47, does not preclude the competent authorities of another Member State from classifying the same product, on the basis of its pharmacological, immunological or metabolic action, as a medicinal product within the meaning of Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1901/2006.

   In this connection, as regards the distinction between medicinal products and medical devices, Article 1(5)(c) of Directive 93/42 specifically requires the competent authorities to take particular account of the principal mode of action of the product. Under Article 1(2)(a) of that directive, only a product which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means may be classified as a medical device.

   None the less, as EU law currently stands, until harmonisation of the measures necessary to ensure the protection of health is more complete, it will be difficult to avoid the existence of differences in the classification of products as between Member States in the context of Directive 2001/83.

   Asymmetries in scientific information, new scientific developments and differing assessments of risks to human health and the desired level of protection can explain why different decisions are taken by the competent authorities of two Member States as regards the classification of a product.

   Moreover, the fact that a product is classified as a medical device in accordance with Directive 93/42 in one Member State does not prevent it being classified, in another Member State, as a medicinal product in accordance with Directive 2001/83 if it displays the characteristics of such a product.

   (see paras 44-48, operative part 1)

3.  In order to classify as a medicinal product in accordance with Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Regulation No 1901/2006, a product already classified in another Member State as a medical device bearing a CE marking, in accordance with Directive 93/42 concerning medical devices, as amended by Directive 2007/47, the competent authorities of a Member State must, before applying the classification procedure under Directive 2001/83, apply the procedure under Article 18 of Directive 93/42, and, where appropriate, the procedure under Article 8 of Directive 93/42.

   In this connection, the competent authorities of a Member State must regard the CE marking, affixed to the product following its classification as a medical device in that other Member State, as having been affixed inappropriately.

   (see paras 53, 55, operative part 2)

4.  Within the same Member State, a product which, while not identical to another product classified as a medicinal product, none the less has in common with it an identical substance and the same mode of action, cannot, in principle, be marketed as a medical device in accordance with Directive 93/42 concerning medical devices, as amended by Directive 2007/47, unless, as a result of another characteristic that is specific to that product and relevant for the purposes of Article 1(2)(a) of Directive 93/42, it must be classified and marketed as a medical device, which is a matter for the national court to verify.

   Moreover, 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, it must be classified as a medicinal product.

   (see paras 59, 60, operative part 3)