Germany’s Federal Supreme Court is currently seeking clarity from the Court of Justice of the European Union (CJEU) on the liability and responsibilities of Notified Bodies under the Medical Devices Directive 93/42/EEC. On 9th April 2015 the German court decided to refer a liability case involving a breast implant dispute to the CJEU and has asked the CJEU to provide clarification on the interpretation of Notified Body liability for medical devices in the EU.
Key questions related to the legal obligations and liability of Notified Bodies that are responsible for granting the CE marking of medical devices before placing on the market have been asked.
The CJEU’s response will have a significant impact on the way the Notified Bodies work and may also be relevant for the future liability of medical device manufacturers in Europe.
Background and Context
The case referred to the CJEU is a part of a legal dispute between the German Notified Body TÜV Rheinland and the patient who had been implanted a PIP breast implant. The German plaintiff had sued the Notified Body for damages when the French breast implant manufacturer Poly Implant Prothèse (PIP) went bankrupt.
For years PIP was violating regulations by illegally selling breast implants containing industrial silicone instead of the medical silicone for which they had received the CE mark approval from TÜV Rheinland. The German plaintiff alleged that TÜV Rheinland did not comply with its obligations as a notified body in line with Article 11 of the Medical Devices Directive. These obligations include the auditing of the manufacturer’s quality management system, examination of the design of the product, post-market surveillance and conducting unannounced audits and products tests.
Now the German Court has asked the CJEU whether the Notified Body is supposed to act with the purpose of protecting potential patients so that the patients are entitled to claim damages directly from the Notified Body. The substantial question addressed to the CJEU is whether the Notified Body can be liable towards patients when negligently violating its obligations.
Perspectives and Potential Impact
The final ruling of the CJEU will set an important precedent for similar cases in the future. It will certainly impact the scope of responsibilities and the liability risks of Notified Bodies as well as the relationship between medical device manufacturers and their Notified Bodies.
Though the latter case concerns only Class III devices, the CJEU’s answer may also apply to Class IIa, IIb and even certain Class I medical devices. It is evidently important for medical device manufacturers to observe this legal development and be more cautious about their product liability risks.
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