By Aurena Laboratories
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Aurena Laboratories OEM medical device and spray products for Private Labeling
Aurena Laboratories AB functions both as a respected contract development and manufacturing organization (CDMO) and also as an Original Equipment Manufacturer (OEM). In this latter role, Aurena offers a range of white label spray products classified as medical devices that clients can develop into their own branded products for consumer and healthcare markets.
These own-label products are available already CE-marked as registered and approved by regulatory authorities. The products are CE-marked as class II medical devices and they will meet the new MDR- directive for medical devices.
Private brand label under OEM arrangements
For any private brand product within the EU, Aurena will be both legal manufacturer and the OEM. This means Aurena will take full responsibility as manufacturer for product quality, efficacy and compliance, bearing all responsibilities towards Notified Body and Competent Authorities.
The process starts with the client choosing a product from Aurena’s wide range of saline-based and other preparations that use Bag-on-Valve (BoV) spray technology for sustainability, patient comfort and other benefits.
These products using the BoV spray delivery system include saline and seawater based sprays, skin and wound care products and more.
CE-Marking and Regulatory compliance
Aurena products are already CE-marked and registered as meeting approval as Medical Devices, where applicable. Products are “generic” or ’white label’ versions of already registered products and are normally provided to distributors on a non-exclusive basis.
The CE Mark is mandatory for products to be imported and marketed within the European Union, certifying that they meet common product design and manufacturing requirements defined by EU Directives.
Private Label Process
The private label offer allows clients to source products direct from Aurena, who has already undertaken regulatory certification with a Notified Body.
Once the design of the new label with the new brand name is finalized Aurena will add the new version to the master file of the original products, ensuring it retains 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.
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.
OEM own-label advantages
Using Aurena Laboratories as OEM for own-branded products delivers a series of key client benefits. These include:
- Verification and assurance that the product conforms with all brand claims
- Development of new artwork, and if needed, language translation
- Distribution agreement between Aurena and distributor, including commercial conditions
- Full traceability vigilance, product change control and post-market surveillance