BBS’s ARTEBONE-product as an example in the Manual of classification of medical devices
The European Commission has published an updated version of the Manual of classification of medical devices and included BBS’s ARTEBONE – product in it as an example of bone substitute containing animal growth factors.
Although the ARTEBONE product developed by BBS-Bioactive Bone Substitutes Oyj (BBS) is not mentioned by name in the Manual, it can be recognized by the excipients and the animal growth factors. ARTEBONE product contains tricalcium phosphate granules and growth factors derived from reindeer bone. BBS is a pioneer in the development of this kind of solutions. In the future, products like ARTEBONE can be classified as class III Medical Devices when the requirements described in the Manual are fulfilled.
‘This updated manual is very positive issue for BBS. It confirms that our R&D and regulatory pathways have been adequate, and that the selected R&D steps, which all have been done, have been correct. The product classification is mandatory for the sales permit (CE-mark). We are now close to the sales permit which is in the application process,’ said Pekka Jalovaara, CEO of BBS.
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About BBS-Bioactive Bone Substitutes
BBS-Bioactive Bone Substitutes Plc (“BBS”) is the health technology company operating since 2003. Before that there was a background of seven years of product development in the University of Oulu. The company has developed a new product for healing of difficult bone fractures and for solving the problems in bone healing. Our mission is to offer new generation medicinal products for the orthopedic surgery. The ARTEBONE ®product is ready and the application process for the CE-mark has been initiated. BBS is headquartered in Oulu and has own production plant located in Reisjärvi.