Own Brand Labeling (OBL)
What is own brand labeling (OBL)?
Own brand labeling (OBL) is a marketing method in which a manufacturer sells a CE-marked medical device, which they have purchased from an original equipment manufacturer (OEM), under their own brand name. Some agencies, including the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, use the term virtual manufacturing instead of OBL.
A manufacturer who sells under their own brand is called a virtual manufacturer or own brand labeler (OBL). They differ from the OEM, who initially manufactured the product. The responsibilities of both these parties—the OBL and the OEM—are defined in the OBL agreement, where, upon signing, the OBL takes on the legal responsibilities of the device.
The OBL is expected to find and appoint a Person Responsible for Regulatory Compliance (PRRC), track complaints, appoint an EU Rep (if located outside the EU), fulfill PMS, perform field actions, and assign and register the UDI for the medical devices they intend to market.
How has OBL changed?
Previously, the OEM could provide the medical device to the OBL but retain their proprietary information. They were responsible for design, manufacturing, and packaging, but now some of this responsibility has shifted to the OBL, along with the device’s proprietary information. This means that OBLs will now have to spend more on regulatory compliance, taking on costs that the OEM previously did. Additionally, OEMs may not find it worthwhile to share their proprietary information and may instead commercialize the products themselves.
Overall, OBL helps to put more medical products on the market, as another company can oversee their marketing. Still, current regulations—while making the companies marketing the products more accountable for the products they sell—may result in fewer companies opting for OBL.