You will find sample pages of Obelis European Authorized Representative catalogues if you wish to receive the full version of any of these catalogues for free by e-mail, please fill in our Order Form, and we guarantee a delivery in 24 hours.

Please also consult our Reference section which contains data and documents pertaining to our ce marking and other services.

European Directives Information

• RoHS 2002/95/EC

  The Restriction of the use of certain Hazardous Substances specifies maximum levels for use of 6 restricted hazardous substances in the manufacture of various types of Electrical and Electronic Equipment (EEE). RoHS coincides with the WEEE Directive as part of a legislative initiative to solve the problems and risks associated with …. » more

• General steps for TSD CE Marking

  Each Device Manufacturer must develop their own compliance program which addresses their particular product categories and business needs. We suggest you contact Obelis (O.E.A.R.C.) for steps tailored to your product. It is important to select your European Authorized Representative before choosing an Approved Body (Notified Body); particularly to assist you in …. » more

• Toy Safety Directive 88/378/EC Notified Bodies

  Notified Bodies are the organizations approved by the national government of their member state as being competent to make an independent judgment about whether or not a product complies with the essential requirements laid out in a European Directive. . » more

• TSD Competent Authorities

  RAPEX serves as a single European rapid alert system for dangerous consumer products. All non-food products intended for consumers or likely under reasonably foreseeable conditions to be used by consumers are included within the scope of RAPEX, with the exception of pharmaceutical and medical products. RAPEX CONTACT POINTS. » more

View all European Directives Publications »

Articles

• Medical Device Registration in Italy

  Synopsis of Italian Medical Device Registration “With reference to art. 14 bis European Data Bank as per 93/42/EEC Directive – 2002 Edition we inform you that on 20th February 2007, Italian Ministry of Health enacted a Ministerial Decree concerning the Registration in the Medical Device Inventory.” The above mentioned Registration into …. » more

• Technical Abbreviations

  This page provide a list of confusing terms that trouble even the best of us. We hope that this page provides some insight into the world of EU regulatory Compliance. CDRH Center for Devices and Radiological Health, FDA. CE Marking CE Marking Approval marking for products being shipped into the 15 …. » more

• Only Representative

  An Only Representative will take care of your compliance and obligations under REACH. This includes not only the registration, but also the authorization, classification/labeling, notification, and restrictions (where applicable) which may be necessary for your substances, as well all administrative procedures. Benefits include: Does not demand exclusivity and you are free …. » more

• Free Sales Certificate

  Free Sales Certificate Many non-European countries request a personalized Free Sales Certificate from the manufacturer in order to place their device within that specific country. According to the European Medical Device Directive 93/42/EEC and the In-Vitro Diagnostic Directive 98/79/EC, CE marked and properly registered devices in all 27 EU member states …. » more

View all Articles »

Special Reports

• 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

• 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

• 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

• 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

View all Special Reports »