Advocate General’s Opinion in Case C-219/15: Potential liability of TÜV for PIP-breast implants

According to her opinion, it is the purpose and intention of the Medical Device Directive 93/42/EEC that, in the case of Class III medical devices, the notified body responsible for auditing the quality system, examining the design of the product and surveillance acts in order to protect all potential patients and may therefore, in the event of a culpable infringement of an obligation under that directive, be liable to the patients and users concerned, provided that the principles of equivalence and effectiveness are respected. The last of these aspects will be a matter for the national court to determine.

Annex II to Directive 93/42 should be interpreted as meaning that, in the case of Class III medical devices, the notified body responsible for auditing the quality system, examining the design of the product and surveillance is under a duty to act with all due care and diligence. Where it is on notice that a medical device may be defective, that duty will require it to exercise the powers available to it under that annex in order to determine whether its certification of the device in question may stand. The precise nature and extent of that duty will fall to be determined on a case-by-case basis, and will be a matter for the national court to determine.

Directive 93/42 should not be interpreted as imposing liability on a notified body to a patient or user of a medical device where that liability arose before the date of the judgment to follow hereon, save and to the extent that the liability in question may already be the subject of insurance cover taken out by the notified body concerned.

Brief Comment

Should the ECJ confirm a fundamental responsibility of the notified bodies in relation to third parties, this would add significant liability to the position of the notified bodies in the Medical Device regulatory system (but apparently focused only on the future) as a result. This is due to the fact that notified bodies are exposed to claims of injured patients. An injured patient will have an additional liability subject beside the manufacturer particularly when it comes to serial damages (e.g. in a recall scenario with a defect medical device).  This fact is also relevant to the contractual arrangements between the manufacturer and the designated notified body with regard to the conformity assessment procedures, since appropriate sharing of liability in the internal relationship would have to be implemented. However, the actual duty under a  direct liability of the notified body depends on an assessment of the individual case.

Eeven if the ECJ proceedings initially relates to medical devices in Class III, a decision of the ECJ on the role of the notified body is expected to affect other devices in Classes IIa, IIb and certain Class I products.

The Advocate General has paved in her opinion the way that notified bodies continue to apply even stricter auditing and control measures for manufacturers of medical devices in order to avoid the charge of a breach of duty. This already follows from the recommendation of the European Commission of 24.9.2013 (2013/473 / EU), but is expected to be strengthened by a decision of the ECJ in this matter. The additional control and audit efforts will have to be paid in first instance by the manufactures engaging a notified body.

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