Regulatory issues relating to electrospinning
A. Wilson, CellData Services, UK
This chapter introduces the concept of regulation of products sold or promoted for medical purposes. The regulatory frameworks for medical devices and medicinal products in Europe are described. Factors that cause a medical product to be classified as a device or a medicine are examined in the context of electrospun scaffolds and the influence of claims or the manufacturer’s intended use upon classification is discussed. Situations in which a product used for regenerative medicine may be excluded from the current regulatory regime are introduced and the progress at European Union level towards the closure of such regulatory gaps is mentioned briefly. ...