Market a registered and approved product
under your brand name.
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.
If so, there are two options available for compliance:
1. Private brand label under OEM CE-mark
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.
2. Own brand label (OBL) obtain CE-mark based on OEM registration
The OBL-company will place the product on the market under its own name and will thereby become the manufacturer. The OBL-company will not design, manufacture, package and label the product, however, the regulatory falls on the OBL. As the OEM, Aurena will hold the original registration files for the product.
Key considerations include:
- The appropriate conformity assessment procedure is correctly followed.
- If appropriate, an application is filed by the OBL to a Notified Body. The Notified Body must review the contract between the “Own Brander” and Aurena, and the documents confirming existing Notified Body approval. The extent of the review will vary.
- Any Notified Body, which may be involved and the Competent Authority, has access to the appropriate documentation.
- Procedures are in place to prepare and review EC declaration of conformities.
- Post-market obligations such as post market surveillance and vigilance are satisfied.
The original company who CE-marked the product is known as the Original Equipment Manufacturer. In this case, it would always be Aurena. An OEM manufacturer of medical devices should be certified according to ISO 13485.
(Own Brand Label / Labeler): The company who is placing their company name on an existing CE-marked product is referred to as the Own Brand Labeler or just OBL.
The legally responsible manufacturer that is also stated as manufacturer on the product. The medical device regulations defines the manufacturer as the company who is responsible for the design, manufacture, packaging and labeling of a device before is it placed on the market under his own name, regardless of whether these operations are carried out by that company itself or on behalf of a third party. It is the manufacturer’s responsibility to ensure their application of the quality system.
The government of each EU Member State must appoint a competent authority responsible for medical devices. The competent authority is a body with authority to act on behalf of the member state government to ensure that member state government transposes requirements of medical device directives into national law and applies them.
In the European Union, a Notified Body is an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For example, a Notified Body may designate that a medical device conforms to the EU Medical Devices Directive, which defines the standards for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE mark, which is required for distribution and sale in the EU.