This means that it should not become a manufacturer, but a solution provider. “manufacturer,” any natural or legal person who manufactures or has fully refurbished a device or has designed, manufactured or completely exceeded a device and markets that device under its name or brand; Notified organizations should note that manufacturers: […] New sections added: What are a virtual manufacturer`s options if their OEM loses its CE certificate? If a virtual manufacturer wants to move from the legal manufacturer to the distributor The minimum requirements in the contractual agreement between the virtual manufacturer and the OEM are listed in the MHRA guide, but below: In 2017, the EU strengthened the previous MHRA guidelines by publishing the EU Medical Devices Regulation (MDR). While the labelling of private labels is still technically permitted in the EU, most notified bodies actually follow the MHRA guidelines, which severely limit aspects of private labelling, and the practice has bleak predictions. What for? The EU MDR and MHRA documents stipulate that the OBL has the same regulatory obligations as the original manufacturer… This means that the OBL must maintain the same technical documentation as the OEM. This is a problem, because OEMs are not too eager to hand over their secret recipe to a potential competitor. But these same OEMs are largely dependent on this symbiotic relationship with their private labians. Instructions for manufacturers who do not design or manufacture devices, but place their names on the product. The design, manufacturing, packaging are carried out by this company. And their business model is to sell these products to another manufacturer that deals with marketing. Until now, it was not expected that manufacturers of Class I or IV devices would register these products. The new guidelines make it clear that this is no longer the case and that these devices must be registered with the relevant certification body. Technical documentation should be well integrated into the manufacturer`s quality management system, with references to instructions for use, labels, risk management, etc.