Under the OEM-PLM process, companies place products on the market under their name that they have not manufactured themselves. This procedure was a best practice under the MDD. But with the MDR come some changes that have far-reaching implications for the OEM-PLM process. In this article, we’ll show you what it’s all about.
OEM, PLM – what does it all mean?
An 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.
A 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. The products are not or only insignificantly changed by the PLM, they are usually only procured, stored and distributed under their own name.
How does the OEM-PLM process work?
Under the MDD, the OEM-PLM process has been a great success story. It takes place along these steps:
The OEM develops the medical device to the specified standards and documents it ready for approval under its QMS
The OEM produces the medical device ready for approval under its QMS.
The OEM approves the medical devices under his name, but usually does not sell any products to users, i.e. does not appear on the market.
The PLM approves the medical devices in a simplified procedure under its name.
The PLM buys the medical devices from the OEM and markets them as its own medical devices under its own name.
However: Own Brand Labelling is made very difficult by the MDR, and the previous OEM-PLM procedure is no longer permitted under the MDR.
Currently, there are only limited options for PLMs to continue to market OEM products under their own label. To do so, PLMs must treat the OEM as a supplier and set up the technical documentation themselves in accordance with Article 10.
Alternatively, the PLM may act as a distributor of the OEM. 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. Article 16 of the MDR is helpful in this approach.
Article 22 of the MDR can be used as a solution for systems and treatment units in some circumstances. It is interesting in the event that the MPC places several products from (different) OEMs on the market together.
Interim solution Virtual Manufacturing
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 intended to help achieve greater transparency and stronger monitoring of the players involved. A corresponding MHRA guidance document, “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers,” was published in March 2017. UK Notified Bodies in particular, such as BSI, are bound to follow this guidance. With Virtual Manufacturing, OEMs and PLMs are both considered legal manufacturers, and unannounced audits for critical suppliers and subcontractors can be conducted. However, this concept also exists only under the requirements of the MDD and not the MDR. Thus, its continued existence is uncertain.
What happens now?
So far, there is no clear statement from the EU on this issue. Apart from the legal text of the MDR, there are no binding statements on the subject.
Regardless of the results of further discussions and renegotiations, OEM-PLM constructs according to the old principle, e.g. EK-MED 3.9 B16, are definitely invalid. Affected companies should in any case contact their OEM and, if necessary, the Notified Body to find possible solutions. Here, contractual solutions for the exchange of technical documentation with simultaneous protection of the intellectual property can be the means of choice.
Further developments will probably only become apparent after the MDR comes into force in May 2020 and will depend on initial practical experience. If you already want to act now, please contact us. We, seleon GmbH, will be happy to work out a concept with you and your partner to preserve your business basis.
Please note that all details and listings do not claim to be complete, are without guarantee and serve purely as information.
