# C_2017112EN.01000502.xml

| 10.4.2017 | EN | Official Journal of the European Union | C 112/5 |
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10.4.2017

EN

Official Journal of the European Union

C 112/5

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Judgment of the Court (First Chamber) of 16 February 2017 (request for a preliminary ruling from the Bundesgerichtshof — Germany) — Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH

(Case C-219/15) (1)

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((Reference for a preliminary ruling - Approximation of laws - Industrial policy - Directive 93/42/EEC - Checks on the conformity of medical devices - Notified body appointed by the manufacturer - Obligations of that body - Defective breast implants - Implants manufactured using silicone - Liability of the notified body))

(2017/C 112/08)

Language of the case: German

Referring court

Referring court

Bundesgerichtshof

Parties to the main proceedings

Parties to the main proceedings

Applicant: Elisabeth Schmitt

Applicant:

Defendant: TÜV Rheinland LGA Products GmbH

Defendant:

Operative part of the judgment

Operative part of the judgment

| 1. | The provisions of Annex II to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, read in the light of Article 11(1) and (10) and Article 16(6) of the directive, are to be interpreted as meaning that the notified body is not under a general obligation to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records. However, in the face of evidence indicating that a medical device may not comply with the requirements laid down in Directive 93/42, as amended by Regulation No 1882/2003, the notified body must take all the steps necessary to ensure that it fulfils its obligations under Article 16(6) of the directive and Sections 3.2, 3.3, 4.1 to 4.3 and 5.1 of Annex II to the directive; |
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The provisions of Annex II to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003, read in the light of Article 11(1) and (10) and Article 16(6) of the directive, are to be interpreted as meaning that the notified body is not under a general obligation to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records. However, in the face of evidence indicating that a medical device may not comply with the requirements laid down in Directive 93/42, as amended by Regulation No 1882/2003, the notified body must take all the steps necessary to ensure that it fulfils its obligations under Article 16(6) of the directive and Sections 3.2, 3.3, 4.1 to 4.3 and 5.1 of Annex II to the directive;

| 2. | Directive 93/42, as amended by Regulation No 1882/2003, is to be interpreted as meaning that, in the procedure relating to the EC declaration of conformity, the purpose of the notified body’s involvement is to protect the end users of medical devices. The conditions under which culpable failure by that body to fulfil its obligations under the directive in connection with that procedure may give rise to liability on its part vis-à-vis those end users are governed by national law, subject to the principles of equivalence and effectiveness. |
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2.

Directive 93/42, as amended by Regulation No 1882/2003, is to be interpreted as meaning that, in the procedure relating to the EC declaration of conformity, the purpose of the notified body’s involvement is to protect the end users of medical devices. The conditions under which culpable failure by that body to fulfil its obligations under the directive in connection with that procedure may give rise to liability on its part vis-à-vis those end users are governed by national law, subject to the principles of equivalence and effectiveness.

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(1)  OJ C 279, 24.8.2015.

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