BBS-Bioactive Bone Substitutes Plc. COMPANY ANNOUNCEMENT 21.6.2018
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 (MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES). In the Manual the classifications of products in the borderline of medicinal products and medical devices are specified by examples.
An example of bone substitute containing animal growth factors has been included in the Manual. Although the ARTEBONE ® product developed by BBS-Bioactive Bone Substitutes Plc (BBS) is not mentioned by name in the Manual, the ARTEBONE ® product can be recognized by the excipients and the animal growth factors. ARTEBONE ® product contains tri calcium phosphate granules and growth factors derived from reindeer bone. BBS is a pioneer in the development of this kind of products. In the future, products like ARTEBONE ® can be classified as class III Medical Devices when the requirements described in the Manual are fulfilled.
Link to the Manual on borderline and classification in the community regulatory framework for medical devices published by European Commission : https://ec.europa.eu/docsroom/documents/29021
CEO Pekka Jalovaara: "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."
More information:
CEO Pekka Jalovaara 050 5529 275 pekka.jalovaara@bbs-artebone.fi
Certified Advisors: Stockholm Certified Advisers AB, tel. +46 70 5516 729
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. We have 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 research and development in the field of medicine requires perseverance and courage to develop new things. We have over 20 years of expertise in this. Our operations are characterised by top expertise, innovativeness and dedicated and committed employees. The ARTEBONE ®product is ready and the application process for the CE-mark has been initiated. BBS is the company having its headquarters in Oulu. We have our own production plant located in Reisjärvi and it is approved by FIMEA. More information: www.bbs-artebone.fi.
