CE Marking (CE mark):   Manufacturer and its responsibilities    (authorized representative, distributor, retailer, wholesaler, user, sub-contractor, own brand labeller, private labeller)  Definition 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. Obligations of Manufacturers When placing their products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in the relevant part of the legislation. Manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable or have it carried out. Where compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity and affix the conformity marking. Manufacturers shall keep the technical documentation and the EC declaration of conformity for ... [period to be specified in proportion to the lifecycle of the product and the level of risk] after the product has been placed on the market. Manufacturers shall ensure that procedures are in place for series production to remain in conformity. Changes in product design or characteristics and changes in the harmonised standards or in technical specifications by reference to which conformity of a product is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing of marketed products, investigate, and, if necessary, keep a register of complaints, of non-conforming products and product recalls, and shall keep distributors informed of any such monitoring. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted. Manufacturers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not in conformity with the applicable Community harmonisation legislation shall immediately take the necessary corrective measures to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. 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? Class I (including Is & Im) medical devices CE Marking procedures Class IIa medical devices CE Marking procedures Class IIb medical devices CE Marking procedures Class III medical devices CE Marking procedures 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