|
Directives and Other Legislation
Where and When
These three directives deal with the free movement of medical devices in the European Union and the four countries of the European Free Trade Association: Iceland, Liechtenstein, Norway, and Switzerland (EFTA). and, they have been transposed into the national laws respectively.
Beside the Essential Requirements the directives also defines the
• Established conformity assessment procedures involving notified bodies and harmonized
standards elaborated by CEN, CENELEC or ETSI.
• Mechanisms available to national competent authorities to manage implementation.
• Mechanisms to intervene on the market when reasons of public health so require.
Changes
Regulation updates are to be implemented in the near future. This concerns medical device companies. Refer to the 2007 version of 93/42/EEC 2007/47/EC presenting the proposed changes. Diretive of the European Parlament and of the Council
This directive should be implemented in all EU member states before March 2010.
|