Case C‑219/15

Elisabeth Schmitt

v

TÜV Rheinland LGA Products GmbH

(Request for a preliminary ruling from the Bundesgerichtshof)

(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)

Summary — Judgment of the Court (First Chamber), 16 February 2017

1.        Approximation of laws — Medical devices — Directive 93/42 — Checks on the conformity of medical devices — Obligations of the notified body appointed by the manufacturer — Scope

(Council Directive 93/42, as amended by Regulation No 1882/2003, Arts 11(1) and (10) and 16(6), and Annex II)

2.        Approximation of laws — Medical devices — Directive 93/42 — Checks on the conformity of medical devices — Obligations of the notified body appointed by the manufacturer — Failure to fulfil obligations — Assessment in the light of national law

(Council Directive 93/42, as amended by Regulation No 1882/2003)

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.

(see para. 48, operative part 1)

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.

It should be noted, first of all, that the Court has previously stated that it does not necessarily follow from the fact that a directive imposes surveillance obligations on certain bodies or the fact that one of the objectives of the directive is to protect injured parties that the directive seeks to confer rights on such parties in the event that those bodies fail to fulfil their obligations, and that is the case especially if the directive does not contain any express rule granting such rights (see, to that effect, judgment of 12 October 2004, Paul and Others, C‑222/02, EU:C:2004:606, paragraphs 38 to 40). It should also be noted that, in the absence of any mention in Directive 93/42 of the manner in which the civil liability of notified bodies may be incurred, it cannot be maintained that the purpose of the directive is to govern the conditions under which the end users of medical devices may be able to obtain compensation for culpable failure by those bodies to fulfil their obligations.

(see paras 55, 56, operative part 2)