OEM/PLM Constellations

It is currently possible to market medical devices that have been developed by another single manufacturer under different manufacturer names. In these cases, large parts of the product development process are typically not man-aged by the organization under whose name the product was placed on the market. However, distributors and others who place medical devices on the market in their own name are manufacturers under the meaning of medical device law and must undergo an appropriate conformity assessment proce-dure, regardless of their influence on the development and production of the medical devices.

Thus, the so-called OEM PLM constellation is a national specificity in product responsibility: The original equipment manufacturer (OEM) develops the prod-uct, carries out the conformity assessment procedure and provides the re-quired technical documentation. Thereafter, the private label manufacturer (PLM) takes over the finished product with its own labelling and acts as the re-sponsible manufacturer under the meaning of the 93/42/EWG (medical devic-es) and 98/79/EG (IVD) directives.

Private Label Manufacturer (PLM)
Company that acts as a manufacturer under the meaning of the Medical Devic-es Law but does not produce the device. The PLM does not change, or only insignificantly changes, the devices which are usually only procured, stored and distributed under their own name.

Original Equipment Manufacturer (OEM)
A company that produces finished products for a private label manufacturer and, in this case, does not act as a manufacturer under the meaning of the Medical Device Law.

[Source: 3.9 B 16 – EK-Med Decision]

OEM/PLM Constellation Not Provided by Regulations
Regulation (EU) 2017/745 on medical devices does not mention an OEM/PLM constellation but requires the manufacturer to have full access to the complete technical documentation. As a result, OEM/PLM constellations in the current form will no longer be possible if, for example, the OEM denies access to parts of the documentation for valid reasons.

Scenarios and Solutions
We can offer an individualized solution in both of these scenarios:

  • Your organization markets medical devices as a PLM and the OEM re-fuses access to parts of the technical documentation, such as formula-tions, source code, architecture or manufacturing processes.
  • Your organization produces medical devices for one or more PLMs but does not want to make parts of the technical documentation available to the PLM for its own benefit.

As a third party, we independently evaluate the entire technical documentation and communicate with the competent notified body and the authority on your behalf. This ensures that the PLM can rely on the contents of the technical doc-umentation without having access to it.
We provide you with an independent expert team of auditors, engineers and scientists and a secure IT infrastructure (including ISO 27001 and ISO 13485 ad-herence). Find out about our services today so you can continue to offer your proven product portfolio to your customers at the end of the transition period.
For questions or for a non-binding offer, please contact us.