CE Marking (CE mark):   Manufacturer and its responsibilities    (authorized representative, distributor, retailer, wholesaler, user, sub-contractor, own brand labeller, private labeller)  The manufacturer is any natural or legal person who is responsible for designing and manufacturing a product with a view to placing it on the Community market "under his own name". The responsibilities of the manufacturer apply also to any natural or legal person who assembles, packs, processes, or labels ready-made products with a view to their being placed on the Community market "under his own name". Further, the responsibility of the manufacturer is placed on any person who changes the intended use of a product in such a way that different essential requirements will become applicable, or substantially modifies or re-builds a product (thus creating a new product), with a view to placing it on the Community market. The manufacturer may design and manufacture the product himself. As an alternative, he may have it designed, manufactured, assembled, packed, processed or labeled with a view to placing it on the Community market "under his own name", and thus presenting himself as a manufacturer. Where sub-contracting takes place, the manufacturer must retain the overall control for the product and ensure that he receives all the information that is necessary to fulfill his responsibilities according to the New Approach directives. The manufacturer who subcontracts some or all of his activities may in no circumstances discharge himself from his responsibilities, for example to an authorized representative, a distributor, a retailer, a wholesaler, a user or a sub-contractor. The manufacturer has sole and ultimate responsibility for the conformity of the product to the applicable directives, whether he designed and manufactured the product himself or is considered as a manufacturer because the product is placed on the market "under his name". Own Brand Labeller or Private Labeller are therefore considered as the legal Manufacturer. Why do you need a representative in Europe? Why must the manufactures of medical devices appoint a EU Authorized Representative? Why is the Authorized Representative different from the importer/distributor ? Why choose Wellkang? How can Wellkang help you? What are included in Wellkangs EU Authorized Representative Service? 11 benefits by appointing Wellkang as your EU Authorized Representative? 3 unique benefits offered by Wellkang that are not available from others? Is Wellkang Group part of the U.S. government or EU authorities? How much does it cost? Competitive Price List! How to contact Wellkang? About Medical Devices Medical device CE Marking procedures Steps to obtain CE Marking for your Medical Devices Legal basis for medical devices Why must a medical device manufacture appoint a European Authorized Representative? Why must inform the Competent Authority? Who should apply/register with the Competent Authority? Changes to registered details? Is my product a Medical Device? How to classify Medical Devices? About CE Marking: What is CE marking? The CE marking logo What is a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer? Why is CE marking called "European passport"? Does my product need CE Marking for the European Market? How to obtain CE Marking for my product? Where can I find CE marking related publications & guidelines? How to distinguish EU directives? Where can I find CE marking testing labs nearest to my location Wellkang® Group is your one-stop global solution provider! Sell to Europe? Here are your solutions: www.CE-marking.com  www.Auth-Rep.com  www.WEEEregistration.com Sell to US? Here are your solutions: www.FDA-Registration.com  www.FDAagent.us  www.510k.org Sell to China? Here are your solutions: www.CCC-mark.com  www.CCC-mark.cn Last updated on