Aurena is more than a contract manufacturing organization. Offering a range of innovative medical device classified aerosol products that are registered and approved (CE-marked), you may choose to work with Aurena as an Original Equipment Manufacturer (OEM) to market a product under your brand name.
Aurena will be both legal manufacturer and the OEM. A new label, including the customer brand name will be designed. Aurena will add this artwork to the existing product list and technical file for the already CE-marked product. Aurena will take full responsibility as manufacturer and will be stated as manufacturer on the product. The client will source the product from Aurena under a distribution agreement. All responsibilities towards Notified Body and Competent Authorities falls on Aurena. A distributor whose name appears on the product will not be considered as manufacturer if it is clear that it is sold under the actual OEM manufacturer’s name and responsibility.
Key Considerations Include:
- Verify that the product conforms with your brand’s claims
- Development of new artwork, and if needed, language translation.
- Distribution agreement between Aurena and distributor, including commercial conditions, as well as: traceability vigilance, product changes, and post market surveillance.
- Products are “generic” versions on registered products and are normally provided to distributors on an non-exclusive basis.
- Once the design of the new label with the new brand name is finalized Aurena will add the new version to the product list of the original products. Aurena will be responsible to make sure that the product is in compliance will all requirements. The new brand version of the product will be included in the ongoing regulatory work with Notified Bodies and Competent Authorities.