Answer given by Mr Dalli on behalf of the Commission
With its communication of 24 August 2010, the manufacturer DePuy informed the UK authorities of the recall of its metal-on-metal hip joint replacements in question from the UK market. On 7 September 2010, the UK competent authority advised clinicians to stop using those hip joint replacements and informed the competent authorities of the other Member States on 8 September 2010 of the manufacturer's recall and their advice to clinicians, in accordance with the vigilance system established by Directive 93/42/EEC(1).
In the context of the Commission's proposals to revise the medical devices directives, which are foreseen for 2012, a reinforcement of the vigilance system is under consideration in order to ensure in all cases rapid information exchange between Member States as well as an improved coordination of the analysis of certain vigilance cases and the identification of trends and signals at EU level. Moreover, the existing obligation of manufacturers to institute procedures to review experience gained from the use of devices should be further developed.
It is not foreseen to include specific provisions in the Commission's proposals which would address the issue of inducement of healthcare professionals by manufacturers because this is related to the exercise of the medical profession which is not specifically limited to medical devices and would fall outside the scope of the medical devices regulations.
As far as clinical investigations are concerned, Section 2.3.7 of Annex X of Directive 93/42/EEC requires that all data collected during an investigation are mentioned in the final report. Section 2.2 of this Annex stipulates that clinical investigations must be carried out in accordance with the Helsinki Declaration of the World Medical Association which contains some guidance on conflicts of interests.