On 16 February 2017, the European Court of Justice answered the questions referred by the Bundesgerichtshof (German Supreme Court) concerning the interpretation of Directive 93/42 on medical devices on the occasion of Madame Schmitt’s file, a German carrier of PIP breast implants.
These were the questions posed to the European Court:
- Can it be inferred from Directive 93/42 that the task of the notified body (in charge of the verification of the quality system, design examination and product control) is to protect all potential patients and that therefore this body would be directly and without restriction responsible for the patients affected in case of non-compliance with their obligations?
- Does it follow from Directive 93/42 that the notified body, responsible for conducting the quality system audit and the design and control examination of the product, has an obligation to examine the products in general or, at least, when there are specific reasons for this?
- Is it clear from Directive 93/42 that the notified body, which is responsible for carrying out the quality system audit and the design and product examination, has a general obligation or, at least, when there are specific grounds for doing so, of inspecting the manufacturer’s commercial documents and / or carry out random inspections?
BCV Lex was eagerly awaiting the Court’s response to these preliminary questions.
The Court responds to the third question negatively; the notified body is not generally responsible for carrying out random inspections, checking the devices or examining the manufacturer’s commercial documents.
With regard to the second question, the court considers that in the presence of evidence suggesting that a medical device may not conform to the requirements of the Directive, that body must take all necessary measures to comply with its obligations.
Lastly, the Court answers affirmatively to the first question and considers that the intervention of the notified body in the procedure relating to the EC declaration of conformity is intended to protect all potential patients.
It has been considered that a guilty fault of its obligations from this body may be liable to require its legal responsibility with respect to the victims. In that case, the conditions in which its liability is required shall be determined in accordance with national law, under the principles of equivalence and effectiveness.
Following this decision, we await the judgment of the French Court of Cassation which will resolve the appeal of another case concerning PIP breast implants.
In early 2017 BCV Lex has requested a stay of proceedings initiated in 2015.
We will keep you informed of the continuation of this file.