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

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Articles

• 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

• International markets attain EU Conformity through local domains

  - Obelis brings the European market closer to your business - Obelis European Authorized Representative Center (O.E.A.R.C.) objective, to support non-European manufacturers and other market players understand and as such achieve conformity with European Directives & Regulations, has always been a primary one, as only conformity shall provide access to the …. » more

• Obelis s.a. @ MEDICA 2011 - Event Overview

  In November, 2011 Obelis European Authorized Representative Center (O.E.A.R.C.) has attended at Medica for the 9th consecutive year with a team of 15 representatives; For Obelis’ team of experts, MEDICA means a perfect stage to meet clients in person and observe their medical devices in reality. This personal interaction evidently facilitates …. » more

• Australia Regulatory Environment for Medical Devices

  There are immense opportunities in Australia for marketing and sales of Therapeutic Products (namely medical devices and their accessories).  Since the sign off of the Mutual Recognition Agreement (MRA) with Europe and the acceptance of the CE Marking for a large proportion of Medical Devices, the importation of products into Australia …. » 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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