European Authorized Representative Center & CE Marking Consultants

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European Authorized Representative CE Marking Consultants

Obelis European Authorized Representative Center (O.E.A.R.C.) provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives such as MDD 93/42/EEC, IVD 98/79/EC, and Low Voltage Devices 73/23/EEC. Our high quality compliance solutions, proven by our ISO 9001:2001 certification, include Commercial, Regulatory, Administrative, and Market Development Services through our Brussels, Belgium headquarters. Our worldwide regulatory solutions are provided through our global and professional One Link One Solution™ Network. We will help you get to the next level.

The Latest EU Regulatory Developments

The new directive 2007/47/EC has implications not only for manufacturers who sell medical devices in the EU but for the medical device industry as a whole. More ».

CE Marking

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... more »

CE - FAQ

What is CE marking?
CE marking means a mark is being placed on products by their manufacturer acting as a statement that the product meets all the standards and requirements of the relevant legislation according to the appropriate European Directives. CE Marking gives companies access into the European market to sell their products without adaptation or rechecking...more »

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... more »

Appointing European Authorized Representative

There are many details to consider before appointing your European Authorized Representative more »

O.E.A.R.C.Medical Device Exhibition Participation

Obelis European Authorized Representative is proud to announce its participation in the worlds most important medical device exhibitions

arab health

Featured:

Obelis is excited to announce the latest OneLink OneSolution advancement. While still retaining the core group of international compliance experts, OneLink OneSolution will begin the process of expanding its boundaries beyond the current service offerings which include regulatory services, language compliance solutions, and new market penetration assistance companies.

OneLink OneSolution will now include businesses from a variety of fields, including marketing, distribution services, public relations, technical writing, and internet marketing. These companies will be carefully selected to ensure they maintain the same superior standard as current OneLink OneSolution members ....