3D Bioprinting Regulations: a UK/EU Perspective

¹ Council Regulation (EC) 1394/2007 on Advanced Therapy Medicinal Products, amending Council Directive (EC) 2001/83/EC (ATMP Regulation).

² Council Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (EUTCD, or the Parent Directive).

³ Council Directive (EC) 2009/120 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community Code relating to medicinal products for human use as regards advanced therapy medicinal products [2009] OJ L 242/3.

⁴ Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation(EC) No 1223/2009, Brussels, 15, June 2016, 9364/3/16 REV 3; Revisions of Medical Devices, available at <https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision_en> (accessed 31 March 2017).

⁵ P, Hourd, et al., “A 3D-bioprinting Exemplar of the Consequences of the Regulatory Requirement on Customized Process” (2015) 10(7) Regenerative Medicine 863–883 .

⁶ “Printing a Bit of Me”, The Economist, 8 March 2014, available at <http://www.economist.com/news/technology-quarterly/21598322-bioprinting-building-living-tissue-3d-printer-becoming-new-business> (accessed 31 March 2017).

⁷ Hourd, , et al , supra note 5.

⁸ European Directive 2004/23/EC (Parent Directive).

⁹ The First Technical Directive (European Directive 2006/17/EC).

¹⁰ The Second Technical Directive (European Directive 2006/86/EC).

¹¹ The Third Technical Directive (European Directive 2012/39/EU).

¹² HTA website, <https://www.hta.gov.uk/> (accessed 31 March 2017).

¹³ M Varkey, and Atala, A “Organ Bioprinting: a Closer Look at Ethics and Policies” (2015) Wake Forest Journal of Law and Policy 275, 288 .

¹⁴ JF Douglas, and Cronin, AJ “The Human Transplantation (Wales) Act 2013: an Act of Encouragement, Not Enforcement” (2015) 78(2) Modern Law Review 324 .

¹⁵ Hourd, et al ., supra note 5.

¹⁶ Art. 18a, Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, 9364/3/16 REV 3, Brussels, 15 June 2016 (MDR).

¹⁷ ibid Art. 2(1)(1) MDR.

¹⁸ MDR, Annex VII Section II.3.

¹⁹ MDR, Annex II Technical documentation.

²⁰ Art. 2(1)(a) ATMP.

²¹ Art. 2(1)(c) ATMP.

²² Recital (6) ATMP.

²³ “Supply unlicensed medicinal products in the UK (Specials)”, available at <https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials> (accessed 31 March 2017).

²⁴ Art. 15(4) ATMP.

* Phoebe Li is Senior Lecturer in Law at the University of Sussex (e-mail: Phoebe.Li@sussex.ac.uk). Alex Faulkner is Professor in Sociology of Biomedicine and Healthcare Policy, University of Sussex. This article is based on the project “Mass customisation governance: regulation, liability, and intellectual property of re-distributed manufacturing in 3D printing”, funded by the UK EPSRC (Engineering and Physical Sciences Research Council, Institute for Manufacturing at Cambridge University, EP/M017656/1). All data created during this research are openly available from the University of Cambridge data archive at https://capturingthevalue.wordpress.com/3dp-rdm-reports/.