With the application of the EU-MDR, the OEM/PLM relationships that have been frequently practiced so far will be a thing of the past. So far, the OEM ("Original Equipment Manufacturer") has been able to concentrate on the development and manufacture of its products and sell them without a name to a PLM ("Private Label Manufacturer") who was the sales expert. All he had to do was apply his own label. For development questions, the supervising auditor was referred to the OEM, who gave him access to the Technical Documentation (TD) and his know-how.
The EU-MDR now does not distinguish between PLM and other manufacturers. There are only manufacturers and a manufacturer is someone who places a medical device on the market - regardless of whether he has manufactured it himself or purchased it from other companies.
The crux: the previous PLM now has to provide the complete technical documentation as a manufacturer. The necessary information on materials, processes and production comes from the former OEM, who in turn wants to protect his know-how. MedicalMountains GmbH explains in the strategy paper, on which ISS-AG has co-authored, how this area of tension can be defused.
The possible procedures described include co-branding, cooperation models and the redesign of products. However, there is "no universal silver bullet" and the approaches presented also contain risks. For MedicalMountains GmbH and the co-authors, it is important to name and weight advantages and disadvantages. In the end, the business partners must find an individual solution to which the authors contribute objective decision criteria. Ultimately, this also means that the authors advise against certain further concepts, namely the trustee model.