The term “biocompatibility” can be defined as the ability of a material, or set of materials, to perform its function by generating an appropriate biological response in its host, in a specific situation. The ambiguity of the term reflects the ongoing development of assessments of how biomaterials interact with the human body and, ultimately, how these interactions […]

In January 2018, the validity of medical device registrations increased from 5 years to 10 years, after the publication of RDC 211/2018. Thus, the registrations granted or revalidated in 2013, which would need to be revalidated in 2018, as the period of 05 years would expire, had their validity extended to 10 […]