Then they can market it under their brand without mentioning to its customers that this product is in reality manufactured by an OEM. The OBL companies will use the CE certificate of the OEM to get their own CE Certificate for the product. Then he will propose his products to some medical device companies call OBL. ![]() On the image below you can see that first the OEM should get a CE Certificate from his own Notified Body. The only change will be the label information with now the OBL trade name. The only condition is for the OBL to not modify the products coming from the OEM. And additionally, he should also create an abbreviated Technical File to be used by the Private Labeler. The Own Brand Labeler, or Private Labeler who should appoint also a Notified Body, uses the OEM certificate to justify that the product is compliant with the European Regulation. The OEM is the manufacturer of the product and should have a CE certificate for its products coming from its own notified body. There are 4 classes, class I, Class IIa, Class IIb, and Class III.With the Medical Device Directive 93/42/EC, this was clear. The OBL also should review the OEM’s essential requirements checklist, declaration of conformity and CE marking certificates, if notified body involvement is necessary for CE marking.Įach Medical Device is classified into the risks involved. The OBL should have implemented standard operating procedures for post-marketing surveillance and a medical device vigilance system. Thus, the labelling (label and instructions for use) cannot be altered drastically, except for modifications to the device name or trade name, or for modifications to improve the label.Ī technical or quality agreement should be established between the OBL and OEM to delineate the respective responsibilities for each party, such as the OEM’s obligation to keep all unit production records as well as any related documents (such as quality system documents) for a period of five years after the last product has been manufactured. Further, the devices that the OBL brands as its own cannot be modified from the OEM’s version and typically only are purchased, stored and marketed under the OBL’s own name. The OBL also must issue the Declaration of Conformity and obtain the CE marking for the device as the manufacturer. ![]() Therefore, If something goes wrong with the device the OBL is also responsible. Once its own name is on the device as the manufacturer the OBL alone has the total regulatory responsibility for the device. Original Equipment Supplier (OES) or an.Several names for the manufacturer who offers the goods under another brand name are Private-label goods are available in a wide range of industries from food to cosmetics to medical devices.īrand loyalty: Private branding allows you (or your customers) to create your own unique image, which creates a marketing identity and promotes stronger customer recognition and loyalty.Ĭustom Tailored: The packaging and labels can be tailored to meet your specifications, including product name, description, company’s logo and contact information.Ĭontrol: Private labelling allows more control over things like pricing, marketing, sales and distribution. ![]() Private-label products (or so called private brands) are products that are manufactured or providedīy one company for offer under another company’s brand name. Private Label for Medical Device Manufacturers
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