Own Brand Labelling- The Ins and Outs

Own Brand Labelling (OBL) in the medical device industry was a term used to define companies that market and sell already CE marked medical devices under their own brand names, despite not being involved in the actual design or manufacturing process. Instead, these companies collaborate with Original Equipment Manufacturers (OEMs) or contract manufacturers.

Here you can check also full guidelines of Own Brand Labelling

In the Medical Device Directive 93/42/EC Notified Bodies used to accept the existing CE certificate of the OEM and an abbreviated technical file, also called Summary Technical Documentation (STED). The STED intentionally left out the OEM’s proprietary information and clinical evaluation data. Providing the OBL companies made no modification to the medical device and just the labels; consequently, OBL companies were deemed the “legal” manufacturer because they affix their own name to the medical device.

As a result of a revised guidance by MHRA (2017), OBL was being replaced with ‘virtual manufacturing’. MHRA defined virtual manufacturers as

‘An organisation that fully sources its own named product from another company (sometimes known as the ‘original equipment manufacturer’), which has designed and manufactured an identical CE marked product. By placing their own name and address on the product, the virtual manufacturer takes on the legal responsibilities for the medical device and is therefore regarded as the manufacturer in accordance with the medical device regulations UK Medical Device Regulations 2002 (SI 2002 No 618, as amended).’

Under the new EU MDR 2017/745 or EU IVDR 2017/746 regulations, it will be harder for OBL companies to obtain CE or UKCA marks (UK market) as they will now be obligated to have a full technical file for any product placed on the market. Information required from OBL companies will change for both MDR and virtual manufacturing. Each guidance includes sections detailing OBL companies must have conformity of devices in accordance with a quality management system. These QMS will be audited by a UK approved Body/EU Notified Body. Furthermore, arrangements for post market surveillance, incident, or potential incident reporting through the OBL company/virtual manufacturer. Lastly OBL companies for the EU market must appoint a Person Responsible for Regulatory Compliance (PRRC) details for their role and responsibility is found in Article 15 of the EU MDR 2017/745.