Bioprinting_EJRR_submission_Final.pdf (107.61 kB)
3D bioprinting regulations: a UK/EU perspective
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 RegulationISSN
1867-299XPublisher
Cambridge University PressExternal DOI
Issue
2Volume
8Page range
441-447Department affiliated with
- Law Publications
Research groups affiliated with
- Centre for Global Health Policy Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2017-03-22First Open Access (FOA) Date
2017-03-22First Compliant Deposit (FCD) Date
2017-03-22Usage metrics
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