Special Reports

• Updated on Dec 28, 2008

  The Revision of the directives on medical devices

  On the proposal for a directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives (A6-0332/2006) Report: Thomas Ulmer (EPP-ED, DE) Report adopted by 645 votes in …. » more
• Updated on Dec 28, 2008

  The role of Non-European Manufacturers

  If you are a medical device manufacturer located outside the European Union or the European Free Trade Association and wish to export into the European Market, you must follow several steps to ensure that your product is in compliance with the European Directives. This article is intended to provide you with …. » more
• Updated on Dec 28, 2008

  The role of European Authorized Representative

  The 93/42/EEC Article 14 and the 98/79/EC Article 10 of the European Directives which regulate medical/in vitro devices in the European Market says: Where a manufacturer who places devices on the market under his own name does not have a registered place of business in a European Member state, he …. » more
• Updated on Dec 28, 2008

  CE Marking Explained

  The European Commission describes CE Marking as a “Passport to Europe” which allows manufacturers to freely circulate their products within the European market. CE Marking is now mandatory for a wide range of products sold within the European Union. Until 1985 the European Directives demanded specific and detailed requirements per product …. » more
• Updated on Dec 28, 2008

  Appointing A European Authorized Representative

  Crucial points to consider in appointing your “European Authorized Representative”: Your E.A.R.has the responsibility to observe the manufacturer’s compliance with the conformity assessment procedure set out in the European Directive which applies to the product. Your E.A.R is there for vigilance intervention; to handle and file the instance of any …. » more