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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

• New WEEE Directive 2012/19/EU (Waste of Electric & Electronic Equipments) is published

  What is the objective? The utmost aims of the WEEE Directive are to reduce the amount of waste electrical and electronic equipment that piles up in landfills and to enhance a more efficient environmental protection. The Official Journal of the European Parliament has published the NEW WEEE Directive 2012/19/EU on …. » more

• 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

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Articles

• Regulatory updates on the standard EN 980

  The European Commission (EC) has published on January 24th, 2013, the list of EU Harmonized standards applicable to medical devices. It appears that two harmonized standards have gone missing: EN 980 and EN ISO 15223-1 are not on the list. Those standards are very important for medical devices manufacturers, as …. » more

• Public workshop by EC on NEW medical device regulations

  The NEW proposals for regulations for medical devices and in-vitro diagnostics medical devices, adopted by the European Commission last September (proposal 2012.541  & proposal 2012.542) were discussed at a public workshop held by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI), on February 26th 2013. …. » more

• Ireland EU Presidency, to influence Medical Device Regulations

  On January 1st 2013, Ireland took over the presidency of the Council of the European Union under the presidency trio of 2013-2014 (Ireland, Lithuania & Greece). Ireland presidency will be between, January 1st 2013 till June 30th 2013. This will be the 7th time Ireland holds this office and it coincides …. » more

• Classification - are disinfecting products medical devices?

  When taking in consideration the characteristics of a disinfecting product for the purpose of product classification , claims may appear to be medical. As a consequence, manufacturers may conclude that their products fall within the scope of a medical device or an accessory to a medical device. The MDD 93/42/EEC, …. » 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

• 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

• 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

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