Appropriately Named,Useful Links As an aptly named and selected starting point from the welcome p

Appropriately Named,Useful Links

As an aptly named and selected starting point from the welcome page, the European Commission has a page directed to “Useful Links,” which may be the second contact point a manufacturer would select. The page is divided into links (the European Commission, National Competent Authorities and others) that would benefit manufacturers with products already cleared for sale on the European market, as well as those attempting to commercialize devices.

Delving further, direct access to the 2010 medical device agenda of events, public health, scientific committees, working groups and task forces, and others are available. Similarly, general, vigilance and clinical investigation-related contact points are offered among the various national competent authorities, which, of course, is helpful for manufacturers with member state-specific questions.

Another section of particular interest to manufactures is the section on notified bodies, which is included under the heading “Other Contact Points.” In addition to the link to the New Approach Notified and Designated Organisations Information System website, the link to the European Association of Notified Bodies for Medical Devices is provided, as is access to the Notified Body Operations Group.

Finally, other contact points that may be of use to manufactures include: the European Committees for Standardization, Electrotechnical Standardization, the European Telecommunications Standards Institute and the numerous European Trade Federations. They all are organized in a single location on the site. On this note and of further assistance to manufacturers with product-specific inquiries, links are available to trade federations for radiological, electrical, diagnostic and dental equipment, as well as contact lenses, hearing instruments and others. Again, this section may provide substantial clarification for specific queries.