title: European definitions, current use, and EMA stance of platelet-rich plasma in sports medicine.
abstract: Platelet-rich plasma has been the focus of much attention over the last few years as an appealing biological approach to favor the healing of tissues otherwise doomed by a low healing potential. In Europe, the regulatory framework concerning the blood system is currently disciplined by Directive 2002/98/EC of the European Parliament and Council of January 27, 2003, which sets out quality and safety rules for collecting, controlling, processing, preserving, and distributing human blood and its components, acknowledged in the various States of the Union with internal regulations. This lack of homogeneity in the European legal landscape will probably lead the Community legislature to intervene in the near future, to even out the "rules of engagement" of this peculiar class of biomaterials.
authors.affiliation: Fiorentino Law Firm, Verona, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Fiorentino
authors.affiliation: Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy.
authors.forename: Alice
authors.initials: A
authors.lastname: Roffi
authors.affiliation: II Clinic-Biomechanics Laboratory and Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Filardo
authors.affiliation: II Clinic-Biomechanics Laboratory and Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy.
authors.forename: Maurilio
authors.initials: M
authors.lastname: Marcacci
authors.affiliation: II Clinic-Biomechanics Laboratory and Nano-Biotechnology Laboratory, Rizzoli Orthopaedic Institute, Bologna, Italy.
authors.forename: Elizaveta
authors.initials: E
authors.lastname: Kon
mesh_terms: D016913:Blood Component Transfusion / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans; D053657:Platelet-Rich Plasma; D013178:Sports Medicine / Q000331:legislation & jurisprudence