Bangalore, Mar 11, 2010: The time between developing a product and getting it on to the market can be long and expensive. Own brand labeling can speed up processes and improve profitability.

 

With so many medical device manufacturers looking further afield for opportunities to expand their businesses, some have turned their attention to a supply strategy known as own brand labeling.

Mr Steve Buxton, Head of Underwriters Laboratories (UL) Health Sciences - Medical Notified Body for the past ten years, believes this practice could offer companies a faster route into the European market. Own brand labellings allows a company to re-brand an original equipment manufacturers (OEM) device under their own company name. There are many benefits to this approach for medical device manufacturers, including; faster time to market, lower development costs and, increased market reach and potential.

“Outside the EU many medical device firms seem unaware of this option to comply with CE market requirements under the Medical Devices Directives (MDDs), explains Mr Buxton. “Many manufacturers elect to follow the conformity assessment routes which are described in the EU MDD and EU In Vitro Diagnostic Directive (IVDD). The process of demonstrating compliance with the MDD or IVDD via own brand labeling is not explicitly mentioned in either of these two directives.”

The Own Brand Labeller (OBL) must take legal responsibility for the devices and make a legally binding declaration that all the relevant requirements of the Directive have been met. As legal manufacturer, the OBL will need to ensure and demonstrate to a notified body that certain regulatory requirements and obligations have been attended to, including but not limited to:

This agreement must make the OBL aware of design changes that the OEM plans to introduce and must ensure that the OEM undertakes appropriate validation of these changes and where necessary to the satisfaction of the OEM’s notified body in order to confirm continued valid CE certification of the OEM device.

The agreement must also ensure that there is two-way communication between OEM and OBL in the event of any incident with either the OEM or OBL labeled device in the market.

The agreement must also identify who within the OEM can be contacted in the event of a technical problem (which may or may not lead to an incident) and confirm that the technical documentation held by the OEM as part of its CE approval is immediately available to the OBL should it ever be required.

The OBL must operate an effective system for gathering information about the device once placed onto the market (post market surveillance). This includes customer complaint information as well as other sources of intelligence about product performance trends, issues and so on. The OBL must also operate a vigilance process capable of determining the need for issue of advisory notices following an incident, issuing advisory notices in a timely manner and recalling defective products when necessary.

Since the performance of some medical devices can be adversely affected by extremes of temperature and humidity the OBL is expected to operate adequate storage and handling routines and operate robust labeling and packaging procedures designed to eliminate product and labeling mix-ups.

The golden OBL rule is that the OBL must not alter the design of the CE approved OEM device – to do so will invalidate the OBL status of the device and would require full CE conformity assessment. The only change permitted is the labeling artwork to reflect the OBL name, address, authorized representative (where necessary) and logo/brand name.

Device claims and instructions for use must be a faithful reproduction of the original OEM design and show compliance with the relevant harmonized standards for labeling.

Overall, Mr Buxton has noted a significant trend in the IVD market place where up to 25 percent of all self-test devices have been placed on the market via the OBL route. As awareness of the OBL option and its advantages grows, it is probable that Notified Bodies such as UL will continue to see growth in OBL.

 

--------------------------------------------------------------------------------