Virtual manufacturing

We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.

When the device is manufactured by the original equipment manufacturer (OEM) and your company name (Own Brand Labeling – OBL, virtual manufacturer) is on the label – your Company will be considered a legal manufacturer.
The manufacturer is any natural or legal person responsible for designing or manufacturing a product and placing it on the market under his own name or trademark.

The definition contains two cumulative conditions: the person must manufacture (or have a product manufactured) and market the product under his own name or brand. So, if the product is marketed under your name, you will be considered a legal manufacturer (Blue Guide 2022/C 247/01) with all manufacturer obligations (MDR, Art.10).
BioReg advises on all label and legal issues related to virtual manufacturing.


In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.

Hi, We are BioReg website cookies and we are here to provide necessary website functionality, improve your experience and analyze our traffic. By using our website, you agree to our Privacy Policy. 10