![]() Regardless of the results of further discussions and renegotiations, OEM-PLM constructs according to the old principle, e.g. Apart from the legal text of the MDR, there are no binding statements on the subject. ![]() So far, there is no clear statement from the EU on this issue. Thus, its continued existence is uncertain. However, this concept also exists only under the requirements of the MDD and not the MDR. With Virtual Manufacturing, OEMs and PLMs are both considered legal manufacturers, and unannounced audits for critical suppliers and subcontractors can be conducted. UK Notified Bodies in particular, such as BSI, are bound to follow this guidance. A corresponding MHRA guidance document, “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers,” was published in March 2017. It is intended to help achieve greater transparency and stronger monitoring of the players involved. The concept of Virtual Manufacturing has emerged as a result of the EU’s regulatory requirements, which were already strengthened prior to the MDR. It is interesting in the event that the MPC places several products from (different) OEMs on the market together. Article 16 of the MDR is helpful in this approach.Īrticle 22 of the MDR can be used as a solution for systems and treatment units in some circumstances. In this case, the PLM would have a very low regulatory burden, but the PLM would not be perceived as a legal manufacturer, but simply as a distributor. To do so, PLMs must treat the OEM as a supplier and set up the technical documentation themselves in accordance with Article 10.Īlternatively, the PLM may act as a distributor of the OEM. However: Own Brand Labelling is made very difficult by the MDR, and the previous OEM-PLM procedure is no longer permitted under the MDR.Ĭurrently, there are only limited options for PLMs to continue to market OEM products under their own label. The PLM buys the medical devices from the OEM and markets them as its own medical devices under its own name. The PLM approves the medical devices in a simplified procedure under its name. The OEM approves the medical devices under his name, but usually does not sell any products to users, i.e. The OEM produces the medical device ready for approval under its QMS. The OEM develops the medical device to the specified standards and documents it ready for approval under its QMS Under the MDD, the OEM-PLM process has been a great success story. The products are not or only insignificantly changed by the PLM, they are usually only procured, stored and distributed under their own name. In this article, we’ll show you what it’s all about.Īn Original Equipment Manufacturer (“OEM”) is a company that produces finished products for a PLM, undergoes a conformity assessment, but usually does not act as a manufacturer in the sense of medical device law.Ī private label manufacturer (often also referred to as a “quasi-manufacturer”) is a company that acts as a manufacturer within the meaning of medical device law and obtains a CE mark, but does not produce the products itself. But with the MDR come some changes that have far-reaching implications for the OEM-PLM process. This procedure was a best practice under the MDD. Under the OEM-PLM process, companies place products on the market under their name that they have not manufactured themselves.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |