Several names for the manufacturer who offers the goods under another brand name are:
- Own Brand Labeler (OBL),
- Private Brand Labeler (PBL) or
- Private Label Manufacturer (PLM).
The original Manufacturer could be named an:
- Original Equipment Manufacturer (OEM),
- Original Equipment Supplier (OES) or an
- Actual manufacturer.
Once its own name is on the device as the manufacturer the OBL alone has the total regulatory responsibility for the device. Therefore, If something goes wrong with the device the OBL is also responsible. The OBL also must issue the Declaration of Conformity and obtain the CE marking for the device as the manufacturer. 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. 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.
A 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. The OBL should have implemented standard operating procedures for post-marketing surveillance and a medical device vigilance system. 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.
Each Medical Device is classified into the risks involved. There are 4 classes, class I, Class IIa, Class IIb, and Class III. If a notified body involvement is mandatory because of the class, the OBL would submit the following for review by the subsequent Notified Body:
- OBL and OEM labeling (label and instructions for use);
- OBL and OEM declaration of conformity;
- technical and quality agreement between the OBL and OEM;
- the OEM’s CE marking certificates, and the
- OBL’s standard operating procedures for post-marketing surveillance and a
- medical device vigilance system.