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3D bioprinting regulations: a UK/EU perspective

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journal contribution
posted on 2023-06-09, 05:32 authored by Phoebe LiPhoebe Li, Alex Faulkner
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).

Funding

A feasibility study of mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printing; EPSRC; EP/M017656/1

History

Publication status

  • Published

File Version

  • Accepted version

Journal

European Journal of Risk Regulation

ISSN

1867-299X

Publisher

Cambridge University Press

Issue

2

Volume

8

Page range

441-447

Department affiliated with

  • Law Publications

Research groups affiliated with

  • Centre for Global Health Policy Publications

Full text available

  • Yes

Peer reviewed?

  • Yes

Legacy Posted Date

2017-03-22

First Open Access (FOA) Date

2017-03-22

First Compliant Deposit (FCD) Date

2017-03-22

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