MEDICAL DEVICES : PIP SCANDAL: INVESTIGATIONS CONTINUE.

 
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To coincide with the publication, on 2 February, of a study on the health risks posed by PIP breast implants, the European Commission has announced that it will release a list of provisional measures - until the revision of Directive 93/43/EEC on medical equipment in spring 2012. This list aims to reinforce, under the current legislation, the surveillance and safety controls of medical equipment already on the market. "In the current situation, patients' health remains the priority. [...] Furthermore, the Commission will discuss with the member states a series of immediate measures to strengthen the existing surveillance and safety controls [...]. The capacity to detect and minimise the risk of fraud must be increased," said the Commissioner for Health and Consumers, John Dalli.

According to his spokesperson, this list will, for instance, remind member states that the 1993 directive gives them the possibility of carrying out "unannounced" controls in companies that have the EC label.

As well as these transitory measures, the Commission has stated that it will continue its stress-testing the current regulation, ahead of the revision of the directive on medical equipment, which is planned for spring 2012. According to the first information available, the EU executive is envisaging: 1. a revision of the designations of notified bodies, ie those that authorise the marketing of equipment with the EC label; 2. a more thorough cooperation between...

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