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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

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Articles

• CEN/ISO 22716:2007 – Presumption of Conformity with Cosmetic GMP in Europe

  Prepared between 2002 and 2006 by ISO Technical Committee 217, Working Group 6, the ISO standard 22716:2007 was published in November 2007. While being an international standard, ISO 22716:2007 was adopted by the European Committee for Standardization (CEN) to become also a European Harmonized Standard (as published in the Official Journal …. » more

• NEW EU Directive Regarding Tooth Whitening Products

  This article comes as an update to the article “Debate on Tooth Whitening Products is Over” published in March 2010 which informed about the European Commission decision that tooth whitening products are classified as cosmetic products under Annex III, Part I of the . » more

• New MEDDEV on Authorized Representatives

  After months of important consultations with different interested parties, competent authorities, industries and the like, the European Commission has released a new guideline document that reveals a major step in the regulation of the European Authorized Representatives’ (EARs) roles.   The provisions of the new guidance document relating to questions of …. » more

• Medical Device Regulatory Requirements For Malaysia

  During the past few years the Malaysian government has been working on developing a novel regulatory system to cover medical devices. The Medical Device Control Division (MDCD), the responsible authority within the Ministry of Health, is therefore, developing and implementing the regulatory framework to manage medical devices (cosmetics are not included) …. » more

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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 the CE Marking as the “Passport to Europe” which allows manufacturers to freely circulate their products within the European market. The CE Marking Directive specifies the manner in which the CE Marking is to be used. Despite some assumptions, the marking is not a symbol of quality, …. » more

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