Own Brand Labelling or Virtual Manufacturing?
Own Brand Labelling (OBL) is a marketing route where a legal manufacturer sells an already CE marked medical device under their own brand name, which they have purchased from an original equipment manufacturer (OEM). The MHRA replaced the term own brand labelling with ‘virtual manufacturing’ in March 2017. The OBL/VM therefore takes on the legal responsibilities for the device by placing their own name and address on the product and is therefore regarded as the legal manufacturer, where there is no actual difference in regulatory obligations between a VM and a manufacturer.
The implementation of MDR now means that the EU has reinforced earlier guidance published by the MHRA in 2017 where “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark”. OBL is allowed in the EU, however most Notified Bodies are following the MHRA guidance (that is based largely on the EC recommendation), which limits aspects of private labelling. The MDR and MHRA both state that the OBL has the same regulatory responsibilities as the OEM (Article 10(4)).
See figure below, which illustrates a timeline of changes in guidance or regulation.
When MDR becomes active (May 2021), OBL continuing business as usual is no longer an option. The OBL is expected to find and appoint a suitable Person Responsible for Regulatory Compliance (PRRC), appoint an EU Rep (if located outside EU), track complaints, perform field actions, fulfil PMS, and assign and register the UDI for the medical devices they intend to market.
For many years, medical device OEMs and their OBL partners had a beneficial relationship that allowed the OEM to protect their intellectual property by providing an abridged version of their Technical File while expanding sales reach through OBL partners. The business model of using VMs is certainly not off the table, VMs will have to work closely with OEMs and this will mean that they will be spending a lot more money on EU regulatory compliance where the OEM has done so on their behalf, and those additional costs associated with regulation may not be worth it commercially. Some OEM’s may also consider that the need to share proprietary information they did not have to divulge the past is not worth it and commercialise products themselves, sell on the IP, or the products may be discontinued and their benefits no longer available.
For all your medical device needs, Mi3 are the experts in designing, developing and manufacturing end-to-end advanced medical and surgical solutions – providing specialist knowledge in injection moulding, device assembly & packaging, thermoplastic engineering, tubing systems, and regulatory compliance. We can also discuss your needs as a virtual manufacturer or manage your product as the legal manufacturer..
Whether you're planning on marketing a device under the new UK rules, MDR or are planning for a global product launch under MDSAP accreditation, our team of device engineers and regulatory experts can advise and support you in your device journey. Contact us today.