Communication from the Commission to the Council and the European Parliament on medical devices. COM(2003) 386 final
This Communication presents the Commission's policy conclusions on the functioning of the medical device directives. They are based on the issues highlighted in the report of the Medical Device Expert Group (MDEG), published in June 2002. The Communication reports on the operation of the Directive's provisions relating to vigilance, clinical investigations and consultation of the competent authorities dealing with pharmaceutical products. The Commission endorses the MDEG statement that the legal framework is appropriate, but that its implementation needs to be improved. The Commission notes that comprehensive data on the medical devices sector are lacking. The Communication therefore announces a study to be carried out in cooperation with national authorities and industry in order to improve knowledge of the sector, of its impact on public health expenditure and of the conditions for increasing competitiveness.
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Record Number: 4997 / Last updated on: 2003-07-09
Category: COM DOCUMENT