3D bioprinting regulations: a UK/EU perspective

Li, Phoebe and Faulkner, Alex (2017) 3D bioprinting regulations: a UK/EU perspective. European Journal of Risk Regulation. ISSN 1867-299X (Accepted)

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Abstract

This section introduces the challenges 3D bioprinting poses to the existing legal regime across bioethics, safety, regenerative medicine, and tissue engineering. We briefly review the 3D bioprinting technology and look into the relevant regulatory instruments for the pre-printing, printing, and post-printing stages. Special attention is paid to the applications of the EU Advanced Therapy Medicinal Products (ATMP) Regulation and the new Medical Device Regulation (MDR).

Item Type: Article
Schools and Departments: School of Law, Politics and Sociology > Law
Research Centres and Groups: Centre for Global Health Policy
Subjects: K Law > K Law in General. Comparative and uniform Law. Jurisprudence
Depositing User: Phoebe Li
Date Deposited: 22 Mar 2017 12:19
Last Modified: 22 Mar 2017 12:29
URI: http://sro.sussex.ac.uk/id/eprint/67156

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Project NameSussex Project NumberFunderFunder Ref
A feasibility study of mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printingUnsetEPSRCEP/M017656/1