Biomaterials: European Regulatory and Legal Aspects — a Synthetic Approach

Abstract

Biomaterials include a wide range of different products manufactured with many different materials varying from metallic alloys and synthetic chemicals to biological or human tissue derivatives. It is thus understandable that different regulatory paths will apply to biomaterials and that submission of files may vary from country to country in Europe to gain market clearance. Under the scope of this paper we will discuss mostly the laws governing orthopedic biomaterials with an emphasis on biological derivatives, which are by far the most difficult to understand, with various legislation in many countries, with a specific chapter on bone substitutes and bone grafts.