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PIP-case: ECJ clarifies scope of notified body’s responsibilities under MDD 93/42/ECC


In the PIP-case, a French manufacturer supplied thousands of women with (allegedly) defective breast implants. Amongst others, patients in Germany started litigation against the notified body in question - TÜV Rheinland (“Tuv”). According to the German Court of Frankenthal in 2013, Tuv did not violate its duty of care. Liability of Tuv was dismissed. This was confirmed on appeal. One of the German patients, Mrs. Schmitt had filed an appeal in cassation. Consequently, through a court order dated 9 April 2015, the German Bundesgerichtshof brought forward several questions for preliminary ruling to the European Court of Justice (“ECJ”) about the scope of the notified body’s responsibilities under the Medical Devices Directive, more specifically the question of what patients may expect from a notified body, and whether the notified body can be liable under civil law towards patients with a medical device.

On 16 February 2017 the ECJ ruled its judgment (C-219/15).

According to the ECJ, the provisions of Annex II to Directive 93/42 do not impose a general obligation on the notified body 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, 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.

Furthermore, Directive 93/42 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.

The judgment fits in the increasing consumer friendly risk environment, which imposes a higher financial risk on parties in the medical industry. With this explanation from the ECJ, it is now up to the German court to determine whether Tuv is liable towards Mrs. Schmitt according to German law. Please note that the outcome does not automatically apply to other jurisdictions as liability is governed by national law. Since Tuv is also involved in litigation in, for instance, France, an international approach is recommended. With their in-depth knowledge and cross-border experience, the CMS Product Liability in Lifesciences Team can assist in cases like this to determine the best international strategy in the jurisdictions involved.

Law-Now: PIP-case: ECJ clarifies scope of notified body’s responsibilities under MDD 93/42/ECC

CMS Law-Now, March 2017
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Eva Schothorst - Gransier