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IVD-In Vitro Diagnostic Medical Devices in Europe by CE Marking
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CE Marking (CE mark):
Manufacturer and its responsibilities
representative, distributor, retailer, wholesaler, user, sub-contractor, own brand labeller, private labeller)
Definition of Manufacturer
* According to the Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008,
- 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" (or trademark*).
- 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".
‘manufacturer’ shall mean any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product "under his name or trademark."
Any economic operator that either places a product on the market under his own name or trademark or modifies a
product in such a way that compliance with applicable requirements may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
Own Brand Labeller
(also referred to as Private Labeller)
Own Brand Labeling CE marking
An Own Brand Labeller (OBL) purchases a finished (or component parts of a) medical device from the Original Equipment Manufacturer (OEM), which he then places on the market under his own name or trade mark (brand label).
This Own Brand Labeller may not be the person who actually designs, manufactures, packages or labels the device.
This economic operator, the Own Brand Labeller, meets the definition of manufacturer as set out in the medical devices Directives. 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.
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About Medical Devices
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