Bone resorption can negatively influence the osseointegration of dental implants. Barrier membranes for guided bone regeneration (GBR) are used to exclude nonosteogenic tissues from influencing the bone healing process. In addition to the existing barrier membranes available on the market, a growing variety of membranes for GBR with tailorable physicochemical properties are under preclinical evaluation. Hence, the aim of this review is to provide a comprehensive description of materials used for GBR and to report the main industrial and regulatory aspects allowing the commercialization of these medical devices (MDs). In particular, a summary of the main attributes defining a GBR membrane is reported along with a description of commercially available and under development membranes. Finally, strategies for the scaling-up of the manufacturing process and the regulatory framework of the main MD producers (USA, EU, Japan, China, and India) are presented. The description of the regulatory approval process of GBR membranes is representative of the typical path that medium- to high-risk MDs have to follow for an effective medical translation, which is of fundamental importance to increase the impact of biomedical research on public health.
Keywords: biomaterials; bone tissue engineering; medical device regulations; preclinical studies; quality by design.
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